-

\' h.+!'f'l f ~Y.t.t\'e ,1t'l"n,HI.Y'e tT·OIt.h

4o~t-A ";1&:'" ;Jttt1l

FEDERAL NEGARIT GAZETTE
.....------_ni._-,'
OF THE FEDERAL DEMOCRATIC REPUllLlC OF ETHIOPIA

If yr,:. ,}uo'1' ·r.'1' C

111'.'1'\"1\'$' t..J.Pl'e 'l.'/oht.(I.!"E tT·llII.h 2QU, Year No. 11
""~h hOli ..,·cX); '~'} Mn.• 'l.?"' . r;h1111 -!-roIll')'· 9"hC fl..). m~1!'r)' flO"! ADDIS ..\ BABA 14'· January, 2014

"'I(JJ-""I. CONTENTS
Regulation No ,299/2013
n·o ,r.'T'C ~f1iil~iU 't.9" Food, Medicine and Health Care Administration and Control
f9"'?111 f "".1:';)\.•).'0 fmS hl1~f\. M ·'·.o;J'.C'i </!'T''T' Council of Ministers Regulation ........................... Page 71.83,
f"'l.'l.Il-rC')' 9"hC 0.·)' nO...................1tl titHifr

f.."'I.'L!rl:C']~~IIC;lkl:J\~I·O' . 1L'J'c...f.ell1{il!.1 COUNCIL OF MINISTERS REGULA TlON No.29911013

hil9"'?l1 T an!':2).:C'!_fl1.'U't..I1'J Jl) ,M'IY.C'i 4t'T''T'C COUNCIL OF MINISTERS REGULATIONS TO
fro"lI''''l.'!.lltC'f 9"hC .n.t . f.111 PROVIDE FOR FOOD. MEDICINE AND HEALTH
CARE ADMINISTRATION AND CONTROL
.Y"'l. ... hrCO)·· 9"hC n.·r Yh. ,rl"l\·Y t"y.t-~'f -'\.'1"h
&.(LY'e tTl1l\.h Mt.1"'l. 1."<\')") I~A"l'!'i 1''?~C This Regulation is issued by the Council of Ministers
"'""'''''''1>. ",lldDlDfI 'I IlIll"llD' h'/' J': 1,'T'C XY.'lli/fo.r I. '!4'l\" I'i Duties
pursuant to Article 5 of the Definition of Powers and
of the Executive Organs of the Federal Democratic
h'i ' 09"'111' ooj(>;)). ,).~. mS "·Ol,fl. M 1·.o;J'.C'i
4I'T''T'C h'/'J': </!'T'C ZfWiNi'i.f II'!.,.)'. ~/:i(Ii) uolPlr RepUblic of Ethiopia Proclamation No. 69 112010 and
Article 55(1) of the Food. Medicine and Health Care
.eun J'.'!11 hro''l':1:A " Administration and Control Proclamat ion No. 661 t:!009.
h'\:." 1.'1.1:' PART ONE
(Il,:t>M
GENERAL
Ii. b.~,C, CQ/)
I. Short Title
J'.1l J'.,)·n "VY""J'O' Vuo)':;~'d'<; hl1'lfI.
VmS
This Regu lation may be cited as the <;Food, M~dicine
M·~.o;y.c'i '~1''T'C V"'I. l.II·)·t')·· 9"hC fl..). Y. '111
and Health Care Administration and Control Council
4I'l'C n :iliIfoX' '/'1111- I\.m·~11 j.'.T~A"· of Ministers Regulation No. 299/2013".
r. T.c.'l~ 2. Definitions
f-"'fl·),?/HI IIA ')'CH" Y°'l.YflfIllD' ~AII'I In this Regulation unless the context otherwise
OIlT"'C OIl.U J'.'!·O (ll>1I'T':- requires:
iiI "I.'I'J':" "'III')' f9"'?'O' Yuo.<:";)·!.'l·'i fmS 1/ "Proclamat ion" means the Food, Medicine and
h-fl'If\. 1.1l-t·.O;Y,C'i </!'r'l'C I,'I'J': 4''T'C Health Care Administration and Control
lI;!;·!ilri'i.~ )0> r Proclamation No. 661 /2009 ;
rl "9"'?'O" "'10')' On'l'~; I.·)tl\" ~(!i) uolll'J. 21 "food" means, without prejudice to the
N-flmo> -l-c' \o'/, ),·IJ'.·I·mo-l' II';" fl9""J-fl definition provided under Article 2 (I) of the
1.9"t-r .l:'a,+ ·ruoc·r· hl.·l.l:' IlAA O<\J'. Proclamation. a product that is produced by
mJ'.9" IIO>"l~ I.'IC 111.1' 7iJ'''I.' N'II;>~ food manufacturer for more than one regiona l
9"C·)· )o>! state or foreign markets.
CI ''1'9.°/11 1,9" b' :)'- " 07(1.). 9"'111 n"'l9",: .).
31 "food manufacturer" means a manufac turer
hh'I.I:' hAA O'lJ'. roM" O(O''L'' 111C 10Y
producing food intended to sale for marc than
7iY'I.' V"'I.4·Cl1 9""J·fl V"'I.yuoC·)· .,.*9"
one reg ional stille or foreign markets, excluding
)(0. r 11,9" IjV~ 'l? 9""}M"1 f"'l.YH,?~;
mi cro and sm all enterprises en gaged in th e
'T' ;/,,/>')<; 1.)1\,,'''' ·"";"~'h hj'.Q;\.9"C9"'
preparation of traditi onal foods;

n.o;· '1';> 14.60

Unit Price );>t·)· ;>1b"1 T."f.</! 1!'i·i.ii
Negari! Gaze!a P.O,bo x 80.001

- - --' - ,, - -
 .... _--_... _-----------------
/
/ m :t7ltitjf'g t..1.(,·{;\ ~.'t'l· :JILI1l {~'l'C It! '1'C X:( ·V) ~i"U~ 'lo9". Federal Nt:g:':lritGazeuc No. II 24111 Jallllary.20 14 P;lg-f' 71 fO
I "".c .._ ===r=
iii "1'9"''}'O J:!J·n·)·" a~.H· 9""HII O·I·'/fl.(Il- 41 l~ fGod sa fety" means th e proo r , ~:l d co ntrol o f
un'}1J(; nfl~7u/..)-; W'"W,:J»:,).r OunYlfl food that is safe for use in the process of
O"'lh"'l;I'-)'<; OU7'Flli lI-tm;l·"'I. O"'lTl11 deli vering food to the consumer Ihrough proper
'/.1'..). 9'''Nl tim,';" 'IN"/"'I, ,~II un If '/- manufacturing, preparation, handl ing, storage
"'Il:J1'1'<; on,~l1]{l\C ~(Il. : and transportation;

li! "9""1'0') "'1·'N."" uM')' 9''''1'O,} 1Ir.r.l,U- 51 "food irradiation" means th e process of
11/.'.1;, W''1,~l\'r 'I:<t 'lh· ktS'PJ:r·'}'1 fl,fl,,:j' exposing. food to radkuion energy to kill
'I'U'PIlf'}'} Ouo",/Y.tI I'.y..£,;t. 1.ltro·'} harmful bacteria and other organisms to extend
1I"'I,HI9" l''''I.hC;m'} '1y..). ~(Il- : shelf-life;

'11 "lI'fUJlI')' '1' ;>'1"l." 9''''111'' ",/11')- IIn7i;t- 61 "potentially hazardous food" mcans food
h9"m 'I' :J>~") ,h'P''\-)' M:1')' (IlM" exposed 10 or capable of support in g the growth
IIODCI':Y' uc3Dl')- r ' I' on;J"f OJ.£,9" r'I',?lIm of disease-causing microorg3nisms or the
9""111 ~OJ' : production of toxi ns ;

1;1 "0-r~"'I.Y 1';1'01- ?<'u/(li··" "'1M, i'iQ;1; ;>C 71 "pre-packed food" means food ,hat was already
hou,\:·ll'\· 06,')- nM"t-'~ 1';1-01 9"'111 ~CD': packed by the manufacturer before reaching the
seller;
r;1 "1-GU"'It 9""'/11" "'1M, "'I'/>,'CD'?" rau!.n>;'
hun ;>1M \,')'1' l 9""'11 'i:'1o).)- 11"'1":/.'1')- 81 "food supplement" means a type of food' that
r"'l.";>~ 1")'I'l 9"'7'0 CD.£,9" &'ILI'II')I,!JA supplement the normal diet and which is a
'I'-r9" ,I''I'!'(Il- r1fJ.',;t-u'1.1 CD.£,9" l''''Io~,} concentrated source of vitamin, mineral or other
CDJ.',9" I'Mj·:y· ')'l'l ~'IC:Y' mm'l CDJ.',9" substance with a nutritional or physiological
0l1]?"t- 1''''I.11·n·)· lH'wM 170m'} 1.,}-'tCDII~ effect, alone or in 'combination, designed to be
;t-Il(l O'ITI'I'A' 01.')I111A i 0'<:-</1,- r taken in measured small quantities and is
Om11;J- CD?,?" 01\'/\ "'",,'VI.£, prepared in capsule. pill, powder, liquid, drops
r"'l.lI;>~ 1'9""/-1\ 't,I'k)- ~(Il-! or any other similar forms;

III "fGU~1\ ,MI') 9"'71\" ",/Ilt hl"-)1l'\ CD.£,9" 91 "infant formula" means milk or milk-like
M'IlA')' 1''''I.1''i (D·H· mM" m1-') aufIA product of animal or vegetable origin
(lNII.-)· tfc;' h'1CJ11 CJl\m, 1'a.),:j<'I ,'hl\'} ¥''''/1] formulated industrially in accordance with the
,(01 goOl')' 01-11t'l 1'-1'11;>)('1 h(ll-A.I'.·} appropriate standard for infant formula and
Mh ooJ':ootyPJ'f. M':Il'} mC 1..I:''''l (Il-Il'l' intended to satisfy the nutritional requirements
'III I'GU-r'l ;hll '} r1'1'l ?""l11 'i:'Io)o)''} of infants starting from birth and during the first
1I"'I"Jk} 1"1-11;>)>; ?""l'0 ~CD' J six months;
II "I',hl\') ?""l-l\" "'1M, 111.')1\<'1 CD}.', ?" h'}IlA')- 101 "follow-up formula" means a milk or milk-like
1''''1.1'1 (D,H- OJj.'.9" CD-t,- ool'\A (Il-m.o)- product of animal or vegetable origin
Ifc;' h"lt)·O CJII(Il- I' ,M '} f"'7·11 .I'.l)/ oul'\(.'}· formulated industrially in accordance with the
n4·11t!J I'-tH,:J)(C; GU~'I .nll')'1 hIl~I1'} mc appropriate standard for follow- up formula and
1..I:''''l 0'lJ.', I'lfn a ,lI,},) llooun7·n 1-11"'1"'1. · marketed or otherwise represented as suitable
h'}!. If~ 1"1'7118 OJJ.',9" 111\/1 UDAh' 10.1' IIJ.', for feeding infants and young children older
I' 'I' II 9""lfl ~ CD' i than six months of age;
Ilil ""'1"'-.1' 9"'711" "'/11')_ 1'1.'1.). m ')' CD·H·' II I "complementary food" means any food
r a.),~'1\ a,ll '} OJ g,?" I' ,hll ') 9""l11 II,MI'r- processed in du~trially. sui table as a complement
1'9"'711 ~II7')- n'!: <'IJ', If,} (\.</'C 1I?"'1fl'f. to breast milk. infant formula or follow-up
"'I":/.,I'~')' '1'1lG'j"'l. If~· 04.11t l l I''''I,H;>~ formula when it become insufficient to satisfy
9""l11 ~OJ': the nutritional requirement of the infant.
"A(D''I' .n.l'(Il- °711')' ?u'711" 121 "genetically modified food" means meat and
f"U,}.I:'Il'f 1'1'lImlll I'll;> m.£,?" edible plants modified through genetic
II.(Il-A 1'G'j, :Y'A I'M'P')- 'I''I'? ~(Il- I engineering;
 -
Federal NcgaritGazene No.!l 24th January, 2014 P:Igc 7185

Ii.'/ "I'I,AI'('\ Ullm'!''' '''M')' tl""I'I".'(o·7" UUlln 13/ "alcoholic beverage" means any beverage
I'I.A/IA ,('.II·)· prim- Ullm'!' 'HJ)·; containing alcohol, whatever its strength;

Iii/ """0'1'" "'10')' O')"I!l: '11\"'1 7""I-n'}r 141 "sell" means to offer, advertise, keep, store.
ao!l:?~.·)·1 ro,{'.?" 1")'7"~tf 9"C')',) 07iy'q;» display, or deliver for sale or to exchange "food,
"'Ipl'O r a'Ul'/''PiD1' r "'Ih"'l'f·)· r
(70 J'11l
medicine or tobacco product in any manner for
M,{',;J- ""q.l{)l "'Ifl·/,I\olj: mf!,7" oullro'!")
consideration;
,(',Q;j,7" t· til
151 "certificate of pharmaceutical product" means a
Hil "'I·C"'IIl.I"·tIJA 9"C')' f'lC·I·lj:h.·)·" "'1M,
?1!l: OO!l:?'d' t.:/' j': ~t'Im· M"?:f I'·/'ool·,. document issued by the Authority or the
manufacturer country regulatory body
00 If'r ') 1''''1•.1'L..?"I'!' O~III" A "I~. ro f!,7"
0"'l.000·0-r ?1C 1'4'''1''16 ?lJtI I''''UI'!' confirming that the medicine is manufactured
by a licensed manufacturer;
M!l: ~ro·!

HI "l'opAIJ9" ?O"t·O· Mt·C" "'It'I-r "'I')'i'arl'" 161 "good manufacturing practice" means the basic
1'7""111 my,l'" l'uP!l:?'d· ?l"'?:f Y.U,)~·"'i principles which any food or medicine
,!,?" r-t·l.971ll 9""1'[1 mg,l'" Y.U')~oj: r manufacturer should consistently comply with
II. 'I'7i~"''i '!' ?" l'1'l.?11ll oo!l:?'i."t· "'17" l')' in manufacturing safe and quality food or safe,
h').<\,:fA 0"'l9u l-r 'LY.7· m'!'~-r ~II(1)o rr'l.;J·
efficacious and quality medicine;
Il.h1·IIm· 1''''1. ?~m' ouv'l;J-'C Mt-C 'UD·:
171 "complimentary or alternative medicine" means
HI ".I'~.?.?&, roM" ?,"M·q;» ou!l:?'!.·r" "'Ill')'
??C fi<l'A l'~tJtI ou!l:?'!.·)· )'Alf~ h'1 a raw or partially or fully processed product
hllou'i'C oo!l:?'d· ;JC ,l'tI'I'''Ioul O'!'t.H, which is neither indigenous traditional medicine
N. ID,IW Oht.A m,{',9" Ouu-/r r,,.4'ouoP
U
nor associated with modem medicine;
7"C'r ~arl

lSI "hJ'.7'i' 11."'I.lltI" "'111''1' (J'l''}:/,41 IJtI·".I'11 181 "dangerous chemical" means a chemical that

mf!,7" MA "I""')' I\f!, IJNPII 011(1)0 lOS I\f!, can cause severe injury to human health if not
h'j:1''i' .,. ...-r II.n.ClI 1''''I.1··A O~III"A"I'" cautiously kept or utilized and categorized as
hf.7'i' O"'l.tI ·'·IIf!,f. N""~O h."'I.lJtI ~(I)o I dangerous by the Authority;
Hi/ "ooC'I"'l 4' i'ii'i" "'11'1.). "'I')'i'(I)o7" ;J-h'l" 191 "hazardous waste" means any waste deleterious
h,)Y.7'1 '!':r7" I\f!, Il.(I)oA r"'lf!,:fA Mm·
to human health and that cannot be recycled;
A'f: illS 1)'. rtn .fIi'ii'i '/(1)0 I
201 "recyclable waste" means liquid waste that
'01 "h '} Y. 7'0 '!':rl'" 'If!, I''''I.ID· tI 4'i'ii'i" "'1M,
could be treated to avoid injury to human health
\'{I(I)o'} illS ~I ,}"'f!,1... ;J-h'l" '!':rl'" 1\.1',
l\.(I)oA 1''''I.1:A 1I.<'I7i .fIi'ii'i ID f!,9" 0""'1.1'1' or waste that could be transformed into usable

'Uo.). 1D'1I'!' O"'IM: ID~ "'" 10:1''''1. ~'IC thing through various mechanisms;
l\.IIID'!' 1''''1. "i'A .fI·Iii'i ~(I)o:

filii "i'ou"lo..I''1 oom'''''l h"''' "'lilt 't1l7" M'j: 211 "frontier port" means· international airport,
?.CTC·r I (J!l:')(JC 1''''1. 7'S 0041"1106.1' M controlling station at border or dry port
1Df!,7" I"A"I1 IJllm· ?IJA N(\\'ou Y.L.:r designated by the competent body;
1DY.11 ~(I)o I

'Of-I "1'1\1\&. 07i:J'" o~M' O'j:,!,~·)· Ooo~ou')­ 221 "communicable disease" means disease that can
hf.7'i' lDL.c7i'S 1''''I..I'flh·)·t\ 07i;J- '/(1)0 I cause major epidemics by spreading rapidly;

rii:l °l)..? '};J- f!,T' "'1M, II!l:'}7''''i' 1'1\1\&, 07i;J- 231 "quarantine" means separation of persons who
1'.?Am'l'A 1Df!,7" OO7i;J-(I)O "'f!,II'1'tI "'1111(1)0 are suspected to be exposed or infected with
l''''I.mllll';' IIP''f'') Mh.l.??'!' !l:lll 0'''''1' emergent communicable disease until the
n;J- h '}.<\, 4' ~ "'I !l: L."I ~ (1)0 I infection is confirmed;
 •
Federal Ncgarit G<l.7.ctte No. II 2-l'h bUlJJr~'. ~0 14 Pat:l.: 7 J lS6
.~
-- ~===
!'ig/ "t'l.e·f· "'NI l")'" "'11\')' 0'/''1'1&, 07i;J' f'l" J'II 241 " is olation" means scp;::.ration o f;J person who is
t'lw· o7i;)'<II") ro.l'.t\.I1":): IlfDT ).')-'l)'ll'l·'Itllj: infected with communic;)ble di sease for certain
M'mM liL Il-flfm· '/·il,l'.-f· )'lltfJ.', "'1.1';(."1 period so that he may not tr:m smit the di':;cJsc-to
'lCD- ; other persons;

?if;/ "f"'l'l'l'lf ~,')1·1j"!-7i"

"'Ill')' Yh(Jl-C'T'I1 25/ "conveyance 9Pcrator" means airplane or trai;l
wY,'l" f~ (l·C 11'[ 'k') roY.'l" filA "'I"r(Jl-'l" captain or the dri ver of any other operato r of
"'I'l'I 1 r 1,'H'I,,!-7i ~m'l conveyance;

ti! "fmS rtt'l"',·)", "'1(\,). rt'lro'1 mS (\oumO:r 261 "health professiona l" means a person registered
roJ.','l" I,·;t. "1(\ .. ,). (\ ua{lIll')' h"l~'O ~(\(Jl­ as a health professional by the appropriate
hlltl h').I'. mS 11M.·)' r'l"uaIl1(, t'l(Jl- (un organ to protect human health or provide health
l'·/·Y.;J;J6. roM" h"'l&·~ fUn'l"" '1(\00'.1'1 services and includes complementary or
u alternative medicine practitioner;
,f,a:l.9 (.· A i

'(;1./ "l'mS ~.?tI"IfI<")· " "'11'1'1' rill." l1(\ou-J'w· 271 "health service" mean s a service provided by a
OU"l O·I· &.4'.r.II')· "l'IllS ou-J' '/'''II1C health professional as per th e type and scope of
M'.~ .)." mll1 oolld· 0"'1.1';(."1 1''''1.11'1' practice permitted by law:
,,1t1"1t'lo,)' ~m'l

?i1;/ "OOt oulll1 010J' 'IJ.'. (''''I J.'.1l- l'IllS 28/ "insumciently available health professionals"
rtl\on-J'!"'f'" "'1(\.). 1.1&·'!? 1j:'1~')'1 "'I"l'l')' means health professionals regarded as
'IY.1t1 t'l."'C OIllS '1'0"!- "'1.'1.l!-~C )''1'd' insu mciently available by the Ministry of
h 1-'1M'I'(IJ' l''''I.fm';' (' illS 11t'\00· J' fDi· Health where the national demand rema ins
"Tw, ! unfulfilled;

?!iif "hilt\" "'1M, h11: rills 11t'\an-J' fOD.J' 29/ lIimpairment" means a mental or physical
M ·en. 1 (\.J'h"w·1 11,!1-'p1 roY-'l" "'1.~"'!?H'1 condition which reduces the competence or
r"'l.J"11l rh6'l"C' roY-'l" I,ll'l'/? u·'I.;1- ~(/}-I judgment of a health professional in performing
his professional duties;

W "l'M'l"C' Uuu?U" "'11'1.). OMI'I' ljlll1! 0"l·)111I.!
nfl"'l.t m!?'l" OI1U(. l\'~. ou;1-(IJ11 'l"111,1't
1',,').1';') t'\ro· 1''''100'111')1 fi(Jl-~;J' ') l''''I1'11111
':(.t'\o;1- rDJ.'.'l" hfl,fI<'".)·· ;JC i'ooDJ(jI1'} aJJ.'.'l"
i'll rD .). C u y-w .). 1''''1.111 ,l'.4'rD-1 "'1"1'1 t
1''''IJ.'.i·tI OooV",. 9"111,1'-1- i'un9"" fiC,\\;1-
1''''I.,I'flLtI1rD- rills ".):"JC ~rD-1
30/ "mental disorder" means a disorder of thought.
perception, feeling or behav iour that seriously
impairs a person's Judgment. capacity to
recognise reality, ability to associate with others
or ability to meet the ordinary demands of life,
in respect of which treatment is advisable;

IfJli! "OO·J',/? J'tllf~ ·t-"IIJC" "'11'1.). Oh'l'7j: 1 OII.U 311 "unprofessional conduct" means the conduct of
.1'.1'0 (M'.'l" "DJlJl1 1Jt'\rD- IV\ m"l roJ.'.'l" a health professional contrary .to professional
f.(.'J{?,1' \"1·.r.~1'1 rmS Ilt'loo-J' oo-J''/? ethics or obligations stip ulated in the
"11'.;1-') mJ.'.9" P'~ 9u "IIJCI 1''''1.:1'1.') '/'''IIJC Proclamation, this Regulation or other rel evant
~(D-I
law or standards;

@~/ "·'·1{;1.;JJ.'." "'I1l~' M·II· ro,l'.'l" 11M MIT>;' 32/ "client" means a patient or user who establishes
wn l'IllS h1{;1. "It'\.+ t'\"'I"I''j.} Iltl 0rD-{;I. contractual or otherwise relationship with a
roJ.'.'l" 01'1.'1 oo{;l.h· hillS Ilt'\an-,I' ;JC health professional to obtain health service for
"I1l-~t r"'1.&.'rc ;1-1]"'1. rD,I'.'l" .1'.10>;' ~rD-! himself or for a third party;

')]i'! "'/'lI;9" " ",(••). fillS mY,'l" l"I".I'.;J;J6. roJ.','l" 33/ "inst itution" means health or complementary or
1."'1 t·sr.- utl'l"'; h 1 (;I. "III" .). oo{J6T.j, ro Y-'l" altemat ive medicine service institution or food
l'9""111 'I'*'l" '1rD- ! establ ishment;

1fJP.! "1''l''''111 ''''1:9"'' "'1t'I.). 0,,'I'jl: ,,'14')\' r(M) 34/ "food establishment" means all estab lishment
ODIPI.·)· l''l''''111 1"1.1';') l''''1.J'h''rD-·) 'hl:'l" undenaking food trade in accordance with
If':' 1''l''''111 ':('C1'C'1 hY,Q;l.9"C'l" I Ankle 2(2) of the Proclamat ion. but does not
include food retail trade;

.. _, .... , ' , ...... _ - - --

 Federal Ncgarit GJzette No, I I 24'j, Janu:1ry , 20 1:t PJ.ge 7187

07;f . "9""/-/1 "'il.:lft':-" "'1M, "'rl'i'(1l'9U 9"'?O') 351 "food handler" means any person involved in
0"'19" L.-r· i fl"'I,),,·ufllr (M!.?" O{/tJl\tJ 'I"})'; food manu facture, import or export trade
I'I/'. (!l'I'I'I' !I9'''''} .:IC ')hh, Nl(1)o (1(1)0 ~£D'l activity ha ving contact with the food;

0'!f "9"'7f1 "'IflA 1."l" "'It.:;. O"~unL.M· (Jl~9" 361 "food forti fication" means (he addi tio n of one
O"'lUOUlIJ. r- f'<lll'l ~ tJ't:tI l'a'l.;J'~-) 1'1,')'; or more micronutrients to a food to prevent or
(Jl~9" r·nt:· 'I'I'L. 9""I£l1' 1>'I'd''I /lonh'ltJA correct a demonstrat ed de fic iency o'f one or
(1l~9" /I"'111(Jl7)'; I, 'IS'; w~9" hlU' 'Ol)~ more nutrients in the general population or.
'1'1' L. ~1C:r·') 09"'7f1 (1)oil'1' ou/Xl,ouC ',(1)0 I specific population group;

ifJ'j,/ "111.'1" OM-c' nr,7i;J- hl\ov.l'1t WM" ... lJA 371 "health"' means a state of complete physical,
1''<;'/'<;' Nlovlf') -or <'l~ln N"l'l I'hlJtI social, mental wellbeing and not merely the
rM9"C'1 l''''IUfll,.,/? J.u')'j')· ~(1)0 I absence of disease or infirmity;

"I'UJ'.(Jl')· hJ':'} S';')I'/'<;' uI,9"'1" 381 "life saving emergency treatment" means a
{hJ'.(Jl-)"} ~,~:> r,f!. 1''''1. 'I'tI 07i;r service provided by any person or trained
1''<;-)- 'I.:Imov(1)o Von9"'/':;: Ou~o'i' rutJ9"'i' professional 10 a patient who has encountered
MA'7I1-')' Mh.n:'; ~'L.I'I 0"'1')';'(1)09" iI(1)o imminent and life threatening disease or injury
W~9" ooilL.;r'f? I' (hY./V-)· h)';') )';')1"'''' until Ihe palient has got access to regular health
(htJ9"'1 Oilllm', ilor f'"/.iI'I' 1,1A '7/1--)' ',or I care services;

iiJii/ "1'.I1:'I1't'i' ;htJ9"'1 MA'7(\·')·" "'1(\-). h"l'<;&. 39/ "emergency medical treatment" means a
h'i' ;hf!./V-)·') M.:I 'If!. 1''''1.'1'A W~9" II"of: medical treatment provided in health institution
.
I'm'i' l'7C ro~ .rOP"l 07i;J' (1).1'.9" '/-.<;-). by a health professional to a patient who has
".:Imon(1)o Uou9"-/'<;'Om'i' -,.,1:"'1-)' (1l'1l'l' encountered disease or injury which could
Om'i' IlMa.y 1''''I,c"\'1' rutJ9"'i' ~11A'7I1-')' result in imminent and life threatening or
~(1)0 I pennanent health problem;

':'if "(hfll.-1'Pll" "'Ill-)' \"/',!,M'. h'I"-)' I'tfH'-} 401 "tissue"' means collection of cells typical in
M"IIC i iI.·c
IIC i l'iI.'L·'i' l'aJ'}~ HC structure, composition and function that are
"'Ioo'J""LP'l'J I 7iA h 'J ..... (}O9" 01.9" M" taken from organs excluding reproductive
tV:,>,)· 1''''1.WIV;. 1.9""" 1'1.9" "''1' I' P''f'l organs such as male and female reproductive
f),('.Q;J,9"C hc"\(1)o~7' I'h'IA h~lI-l 1''''1,(J}(lo'l. organs, testosterone and progesterone, fetus and
O:'>Cl\' I Of!.I1-)·" flo/''7IlC -I'ov""~ rtf'1- blood or blood products taken during blood
rU'!'ll llflll'O ~(1)0 I donation;

{filii '''):'>iI ,,'M" "'1/1')' Mf'· '1'1<; r;lltJ9"~' H~ 411 "transplantation" means substituting, through
O{hf!./V-)· '11'1 /V,('.9" ;t.,eaH ',iI&' c"\w,
surgery, a patient' s infected organ or tissue or
I'-NI1c"\') fMtI 1,'I=tI wy.9" ;'>11L.-1'1'1'I
that which is unable to perfonn its normal
Oou(1)oil.l1: 1';r'I"'1.'I OO7i;r I"/'m:l' rof.9"
function by donated organ or tissue from a
Oh'71l0' on1.n'" -/-'7IJ{',} 1'°1.1'h~·ro·-) I'''''IA
h~A wJ',9" ,hfll-1'1'1'I "",/",,). ~al'l
living or dead person;

~jll.l "illl~ (\t·o "·'·'PM'· · UlIY""" "'1M, I'W-»';') 421 "artificial reproduction service" mea ns the
I'IIC ~:~ flo/' t. '1'C' h"'1.;r(lI</,(1)o 111. Mill' introduction of semen into a
ooAh· (JlY. iI.:J: (lIol\fll'f \'00/'·0..1' hll"')' female's vagina or oviduct for the purpose
/I(Jl/l ..I1: ~""'1 "'1{l'/',,/I<,: i'l.tf'l O·/'IXl."'1tyo of fertilization by means other than the natural
1'(Jl-»'; 1>'i' l'iI.')' IIC '1'Y"l')' (1)om')'-) IIi:: way and includes uniting spenn and egg cells
h-/"lJJiI.I'.(1)o "'1,n?') (1)01'1'1' /I"'1I'1-/-'IM: externally with a view to introduce the fenilized
hiI(Jl·~-)· hilA (Jl.r.b1. I'm-).\'; l,~' l'iI.')' IIC') sperm and egg into such female's reproduclive
"'1</,'I</,A ') Y-(.!.\.9" /,. tu organ;

~m ... h'l. •..e" "'1M' Y°'7-0 mf!.9" ao.'{,· 'd''J 431 "distributor" means a person who distributes
II ... '})'; IrAA lillY, II"'1M·t.A p/.. II~ food or medic ine products in more than one
regional state;
 h?d~'ra! NcgaritUazcltc No. I I 2·1'10 J;mu;w-,", ~(il 4 Page 71!S8

44i "Authori ty" means the I:lhiopinll Food,

Medi::ine and I-Iealth C:!re ;\d mi n j~lrat ion and
Conl rol Authority;
45/ other definitions provided under Artide 2 of the
Proclamat ion shall be "pp li c;'h l ~.
PART TWO
IJ~'" INI7-
FOOD AND MEf>IClNE
1'9"'7j)'i'~~.I'.'~LM'tllf.C'l 'II'l"!,C
ADMINISTRATION AND CONTORL
9"06-'1: h').I'.'
CHAPTFRONE
\T''''Ifl .r.JW7-'!._~6-:t
FOOD SAFETY AND OUALITY

"'I'i'l'arr lim,'; '/'1)0'1"'1. YtllJ'~ (lJg.9" '/-7fl.ar')

3, General

V.I'. v'n')'" '1' t·')· .1'.01 YtlmtH 9""I·fl il.no/.'l· ; No food unfit for human consumption or not
ro.r. h1C m·il'!' il,7fP m.l'. (lJ'''1'' h1C il/I)I' comply ing with app ropri ate safely and qua lity
il.h"·(f· i II.M.t. A ; 11.'1'11/ aJ)'.9" il7i.P"1" my.?" standards ma y be manufactured. imported. exported,
IIVfll.·/·lIfl· 'l'T?n 1I.(lJ·A I,Y.i·... 9" :: stored, distributed, tran sported or made available for
Ii . 9" "'I fl') M "'19"I. 7- sale or use to Ihe public.
iiI ?U"'I'W} h/,'},I': ))(.\(.\ fl/I,e 0),l'. 9" il(lJ·r.tl. /,1C 4. Food Manufacturing
10Y 7iY"l.b 1'°~•.I'4·Cl1 h9"6-:)" OIJIlI»(.\fTJ'r II No food manufacturer may, wilhout registration
<'IYilontl"l'(]" t ..4'.I'.' <'1.1'1"1 .I'oDI.·I·ar'l 9""111 and pemlit rrom the Authority, sale food
il'liY"1" "'I:rl.fl m,l'.9" I'9"C')·; r'l,{'.~·h· product intended for distribmion in more Ihan
1''1..r.')' ilar'l' "'1.1'.'1."1 h,{'.'f· ... 9":: one regional state. or for export market, or
change th e type and production process of the
III IJIlp'Anl~' OILV /,'}-I'X' 'lo·f1 /,'HlI' (ii) food.
UDIII.·)· \''''I.UDH''IOar ro,{'.9" 6,:/>.I'.' 1''''I.ilmar 2/ The Authority shall register or issue a permit in
VooNI9" 1'11006-1.')' Mt-C I 1'9""111 accordance with sub-anicle (I) of this Anicle
.r.\n~·)·" '1'6-')' "'0':·.,·,: 9"Co D ':, 'h" upon ascenaining the fultilment of good
fl.il· i·'l" hIlt.o\'/, onM.Cf·':(· UDO,.";J·'far'l manufacturing practices, food safety and quality
fl"'lI.;>1'l' ,l'.If""':: laboratory test and other necessary

I'/\,V h'I-/')\' 'IMI h'}4')\' (Ii) .I':').n. requirements.

'h'l.l'.'/'mfl4' If'> 1J1IP''''fTJ~· 3/ Without prejudice to the provision of sub-anicle

! ill] 'fm· 'l 1'9""'111 hJ!, H·T (!) of this Anicle the Authority shall adopt
directive determining the kinds of foods that
J!,mil""'::
shall be registered.
~. 9""1fl,) MUDhltfl'l Mcn>fI(r M"'I~ 1.-11
5. Food Adulteration and Counterfeiting
iiI fl"'l'l'l'm'9" 9""'111 f\J!, OO/ll'r') m,{'.9"
1111.r.·f:'l ilUDIX\,OOC I UD ... h·'l II It shall be prohibited to add or mix any
substance to any food so as to increase its bulk
mJ!, 9" M.o\ -t aD '" '" J!, '1""'1 il)1 tI
or weight, or make it appear bettcr or for any
aD Q;l, UDC m ,{'.9" no -I' 1\ -I' tI r ./' hil hil ~ (II- : :
other similar purpose.
J./ "'I'lt;'m··)9" 9""1-11 h"'l'l'i'ro'9" fllar'l mS
2/ It shall be prohibited to partially or completely
11.1.<1 h"'l. Ttl (liM" 1'9""1fl''l 'l'6-'l-'l
embed in any food anything hannful to human
.r.V'l~·)· 1I.!'1.1'.'tI h"'l. Ttl ~1C ;>C flh& .... 9"
health or that can affect the safety and quality of
If~ on·n, Oon-n· uU,I'.'lI'lT r 'I-hI'lhn ~ar::
the food.
(I "'I'I'i' ar ')9" 1'9""'1'0 "'I7i'/,! I ooM i I"l"'l.l':
'l"tll1-j'; V·}U}.I'.' il9" mJ!,'I" "'I'g'ar'l9" 3/ It shall be prohibited to present any food as if it

'l,l'. ~.). tIf.

9"tll17- floom4'9" 9""Ifl' is produced by the real manufacturer or

O'har~'/''i'ar 119"':·':(· 'h'l.r.-tool.·1· fl"'lilooiltl affecting quality and safety by imitating its
m,{'.?" 1'9""I0''l 'l'':.')'" .I'.V'l~·)· M.I'.'(r package, identification, trade mark, trade name
"'ITl.fl r'I'hilhll ~ar:: or any mark.
 n' i.7i.Iif-irilt.. f.t·1.\ t'kl' .7!Lr11 'i~'T'C X,~ '1'C .~· X ."') ~i'i.X ~.~. Federal Ncgaril Gaz('ttc No. II 241b JanuaJ)',2014 I'ilgc 7189
======~=======================
I 6. food Stor.az~TrRn50ortation and Disolav

!il "'I'g'oH" \'7"~J-fl

M " t. :1" , 1111. ' M1""(,I;',
o>~,')" ~\M.4. ,e .r;c:6· .'j.ft- 1l.0117i 1"'?:r·tI
r"l 'Il'} (1°Y..l'll"'lTO·)·; til)}?;}' n "'I.J"~C:1ln·)·;
n o v ' 7i"ln,)· m)',9" n a U'l1'7JfI')' UI. IH·?o.o>-
roo·d· OI'lll 'j m!.',?" N '?I:"I\' (l'I(ord' t'l)'{)'l'
ooU"i i~tWi~~"::
II Any food manufacturer. exporter, importeJ or
distributor shall store, display. pack or transport
perishable food at appropriatc tempt'rature or
cold chain.

'1.1 "'11>;'0)09" 1'9"°NI ~\ rt·:r! MuuGr.i. 21 AllY food manufacrurer, exporter. importer or
o>J?r hhH.l'. J'.·C1':·)· "'I'1'l11 distributor transporting food on or in any part of
1''''1. T(Oo>- h9""I0' .X 1hh. a vehicle may only be possible where that part
f°?'l'l~r h<j:tI ')frll If~' \1'''70-1 (0"'11>;'0>-9" has been cleaned to such an extent that
h. "'I.IJI\'E ! h 1111 'I? m,e9" "'I,ehC: ~r·ft-)'t Ij tI chemical. physical or microbiological
11M')' n"'lf ,?A'l' avAh· o-oU"} MO')':: contamination of the food is prevented.

!.'I "'I1'i'm·"?" 7'''7 ·n h'~nht'l 9""I'0 ! h9""Ill 31 It shall be prohibited to store, load or transport
"'·C<j:6·P hODC1" 1· )t hlf;" ~?C'f ! hh'){) any food together with contaminated food,
ft,)· Ol)'.9" Ilt>(o°',f· OilY. 'I?C'-:;' ;JC "'Ih"'l waste food, poison. any hannful substance,
:f')'\ U"&·L') (1),('. , . "'FFl'1I ~1,MltI '/11).:: animal or any .other contaminant.
~. r"l-n1 M"'InA)\ '1 7. . Food Fortification
til ~1Ip'tllTJ~' rlJlll'l·ron·') m.'J l'loomn<r 11 For the purpose of protection of public health
rr"l'o "rt-"f' J,·C'f.+ f"'l.)'avC·/·0>-1 r"lll the Authority may order any food manufacturer
n'rM' \( "'IM:C;')'C; i'iJ?;J-°?S'f h1.<t0Illl'''1 to fortify food with different minerals and
"'11111 ,e1'..-. tI :: vitamin .
III "'I""W:9" ?7""I·n '1'*9" Oil.lJ h')1'1I' 10'{) 21 Any food establishment may only manufacture,
h1'~lI' (ti) opu'l.t h1.<t01\l\,"1 r'rllf r"l-n1 import, distribute or sale any food identified for
fortification in accordance with sub·artic\e (I )
"'9"1.')' f "'Iflt1Dtrl'}. f "'I114.U\ O>J'.?u oo7i'l'
of this Article where slleh food is enriched in
1''''1.1-110>- ~MtllTJ~' ~mffJO>- oo{)&,C')' accordance with requirements adopted by the
00(01.')' rOil?? fo.lf·) ~o>-:: Authority.

i:1 rnl'l"'1 9"'111 711-l" ?' lJ·<j: 7"'10, rnl'l"'70')"} 31 The labelling of fortified food shall contain the
"'101:1 O>j'.9u ii,e;J''''I:1 r"'l.7Atl IJI."1 phrase stipulating with what mineral or vitamin
tlSlo>· Y.7CJA:: the food is fortified .

. ~. r"l1l1 "'.",." 8. Food Irradiation

[il r"l'o r"'l.,f'£Ll.C ·/,\I;r '!'7flavl f1.V1'I')'" II A food irradiation establishment shall be
ru,e;tt') ou{)&'c,H') n"'l.)"',!1 ouAh' .<t~y,'} designed (0 meet the requirements of safety and
ouf-I.,,} .rscn;J·t\:: good hygienic practices.
ff.! 0"'l1<;,o>-r 9u "/'n ft. 'lC 1''''1.7~0>- 1't.,IU' 21 The radio nuclei remain in any food may not
'Lo>-h-ll,e ,j' tA· '~ 1'~J?J j-}. 111'10>- oPm') exceed the acceptable limit.
oullt'l'l' rtln}9"::
/I. r"l1l 0>1. MC O>-{)'l' M"'IIl7CJ=,/''j' (J}!'. o>-~ 9. Food Import and Export
M ....,\h
\ II Any person may only import food for public
[il "'I1'i'0>·r flo>- tlVlll.1't'I·n h1A"}ft-')- consumption upon obtaining permit issued by
r"'l.o>-t\ 9°'1111 0>1. ,,7C o>-fl'l' "'I1l7/j.). the Authority after ascertaining the safety and
f"'l:NI(J}' /j1'lP'tllTJ'r \'9""10,' Y.vntc; quality of the food.
'l't·')- il"'ll,:>7'r c'l.J.~.£: ",lfC;t\::
 •

17t' :~o.tirl t.,~',(;,C\ ~.7t} ?IV'l 1:'1'C Iti 't'c n .,.-, MTLl Ii.?". Federal Negarit Gazetle No. II 2·I,h .lall uary , '.' 0 14 Page 7190
-"""""'========""""""===;~==,,,=---- --.-.-.--'=~- --
V-I '1f1P't\f'l'r hm'''1i> MC 1'1'1 9'''']'0 )'.tJJH:<J 21 Where the Authority ,!Scemin, that imported
'l',H: YA'I'mO '~ ",,[J'~-')
Ill,:J7m h"l'111 food is not safe and is of poor quality. it may
(U:O)' ~oj'}I>'.· h '}Jt iD?~' m,£.9" ro~ oofTlO")' order its appropriate disposal or may ca use to
h1C ),Vtaollfl Yfl)'.C;;tI:: be returned to the country of origin.

L'I '111P'C'.fTJ'r :wu"l'r, "'h.m· '1'9:9" ItmN>
P9"C'/O 1'I\·I1&'-I'·t 9"Co<>&. f9 D ilhC (1)<'.4")"
nh1C IDN!' '101' 'If. 1,')P.ortl l'-t-t_,/,I_
MdO[J'~- I"'-om f9"flhC iDl,/,')-
I'mS l'9"flhC iDl<j>')- f.offlA::
3/ The Authority shall, when requested by the
exporter, issue a certificute of lab~ratory
analysis, a certificate of authorization to sale the
mf.9" product at the local market or health certificate.

I. M:t..Q;I,"'I t it <J tlor'!' ",yor 9""l(l'f 10. Food Supplement and Genetically Modified
'fil "'I')I1m'9" flor '/,Q;l,"'It 9""l(l'l-J fl1i,l'''L' Foods
"'Ii'lll 1""/. ):flw- 1-Q;l,"'1t 9""l0- II Any person may only sale food supplements
11'1I'\P' .00"l',- '!-0"'11'10 o.t,</' J': ;'.U'<J iii:: upon the registration and . permit of the
fl "'D'i'ar9" OiD' n:rJ':"'1,J' f;t-j~1 ),<J "'rQ;l,"'It Authority.
9D "l1l" I"''I.A 1'l"L' )\ U-~ "f.<:' lor 21 No person may sell a food supplement unless in
"'1JI1orJ9" '/'a;a,"'1t 9""l11 ooi'i'!' hf.'I'Mo:: pre-packed form and its labelling contains the
fl "'IJ'i'iD-9" I"f-tn"'1t 9",,/,0 1""L" )\ ().~ I phrase "food supplement".
)'4't-ll1 CO!!,9" "'Ifl;t-co<f!Y Nnufflm~<J 31 No labeiling. presentation or advertisement of a
I"MYI' hdO?1'O 1-1fl.or1 1'1' r.c'. 9""/11 food supplement may describe that a balanced
onm') ),1)'. "'IJ'M'1 iD$?9" '!-Q;l,"'1 t 9""l(} and varied diet cannot provide appropriate
VOiD") n7i;J' ),1,t"'/,hIlhA iD$?9" ),')'."'I.,J':1 quantities of nutrients or attribute to the food
1''''1:1A7.' ooln I'MI')'9":: supplement the property of preventing or
p} "'I1'i'orJ9 D tlor'!' ih,l'or 9""l1l fI"'I9"I.')·' treating a human disease.
IDJ( MC oril'!' fI"'IM'l')' f iDf. or"L' h1C 41 Special pernlit of the Authority shall be
flOOl\h w$?9" fI"'1M.t.tI lJrlflp'tlffI't- tI r. required to manufacture. import, export or
t.:I' J': ,I'flt.A;;A:: distribute genetically modified foods.
(;1 "'1'l~<or9V (tor Aor'!' ,'h,or 51 No person may sell genetically modified food
n:t- f.''''I,J'
I';t-7i1 "g.If'l<J " Aor'!' unless in pre-packed fonn and its labelling
1''''1.A 111"L" l\'iJ'~ "$?<:'lor contains the phrase "genetically modified
hf.):A?u:: food",
U. rQ;l,~I\<J r iMI<J'}' 9"'?(I"f<J "'I"U' 9°"/(1':(' 11. Infant and Follow up Formula and Comple-
mentary Food

iiI "'IWor19" 1'6tl.i''''' tJlI<J'}> 9""/II"f'l iDf.9" II Special permit of the Authority shall be
"'I"'J.J' 9""lIl"l···) 11"'19"1.')" Wf. h1C iDil'!' required to manufacture, import, export or
iI"'IIl?Il')" IDf. or"L" h1C fldOllh cof.9" distribute any infant and follow up formula or
fI "'1M. UI h'1 fI P' tI ffI'r A r. t.:I' J': NIt. tI;J tI :: complementary food.

fl IlflP'AffI',. I')'<J')' m")- OJ'/"}' 9"')-h "ll1f.')·'l

21 The Authority shall adopt specific requirements
regarding the marketing of breast-milk
I'°'l.onflll'l· 1JC1IC avlt&.C-I'· if') "willA::
substitute.
II. hMI .,.l\;;t I'or'! )'i'C(l1- 12. Trans-Regional Water Supply
"'1'l'i'ar9" oor htlA -t-'li;;t l'iD''1 h:t-cM· Any person may only carry out trans-regional water
h1A,,/I\·')· avflm')' l''''I.ifflor M (Jl-'/or '.tJ'l~')·<J supp ly services upon the approval of safety and
'!' t- ,). hIl flp' A ffI 'r "'Il?1 ""I. c'I. om or 111 ~ or :: quality of water by the Authority.
Ir. Mhtl/lt\ 71r"L' 13. Sale of Alcohol

iii "'I')'j'iD'9" OMltlJ J(l)1 ,ruoC-I'· h),Jf: hAA
o1If. 1''''1.0 t- "L' ; II or "L" h 1C 10J' fl7iY"L'
.e.
I' "'I. 4'C 11 iD 9" (!J .I'. h 1 C or II'!' I'"'I. 111
l'),tI/lA oom'!' h"l'l'O ,I'flor h!JtI ,I'lDfflorJ
J(l:q \'°'l.,1'''lll ODU") MM· ::
II Any alcoholic beverage produced at industry
level for distribution in more than one region or
for export market or imponed for local
consumption shall comply with the standards
prescribed by the competent organ.

_._-_ -._---..
 Federal Ncg.arjtGazl:lI~ Nn. l\ 24\h J:"lnuarY,2.01-l Pag~ 7 19 1

~I OII.U (,'H?" 'IMI {,'H'?" (i» OOU'/.')' t'l7is'''!.'' 2/ Alcoholic b~ vc ragc supplied to mnrkl'l pursu3m
I''''I.-/'C't! 1'l,Ai'A n"m'" IlMlC noo'f, n;J')' to sub-art icle ( I) of this Article hovin, less than
rtf', if1J·i:~m· 9° aom'·P ~11't6~ ~.h,G~
ten per cent of alcoholic content sh:11! state it s
1'r,IA"IIl-')' 'W:, ",'''Ill'!; ,l'.';·Cfl;t'6I.::
expiry date on its label.
;;1 '111/~Af1l'/' 1'{,tll'A nUIll'r '/:'l"rC) /H '(/O
31 The Authority shall issue directivt: regarding
1I1l'/' aunut..r ,l"m"lA::
regulation of alcoholic beverage.
l",p&,lj: U':'l-t CHAPTER TWO
\,un!'--;'-)•.:).:_J,j),r.lll,G£1:'1"l'C MEDICINE ADMINISTRATION AND
CONTIWL
Ii1. {'.!!!t'_,\f, 14. Gener:"
"'I',>;'m'?" 'rl.,'/:; ,f.u"H'l t,'I'n~'~ YA'/'/.;J No medicine the quality, sofety and efficacy of
'1m uuY:;Yd' "'19"/.')'; mY, (,lC m'Il'r which is not ascertained may be m;mufactured,
"'IM'1.)- i m,f, CD'''!!' ('IC uul\I]; "'111"'1'1")'; imported. exported. stored, distributed . transported
"'IM,',A; "'I'n-II {Il,l',?" IIny"!." ro,e.?" or made available for sale or usc to the public.
lIu,n/.·/,I'In' 'NY" ",l'. ),·).<',,(O,A "'I!,-'/',,/ r'l'hIIhll
)m·::
15. Manufacturing and Certificate of R('.gistration of
Hi. Mao!'.';)'!,:}' 0'19"1.·}<; ?"1l7'1 ?"llhC m/.';'} Medicine
iii "'nr;'m'9" \,u n )':;:>';:)' ),Y""'1'· roW/" roh.A 11 AllY medicine manufac.turcr or an agent may
"'I?"/.'l' my.9" <DJ', r,'IC m'Il'r "'IM'l')'
only manufacture or import a med icine that i's
1''''1. i'lIm' O,ntl"lr'p' au )!:;>'l.'} oollCllC
included under the nationa l drug li st.
m'Il'r \"/'Il'I'-I-', UDJ':;>~:)' '110'::

Notwithstand ing sub-article (I) of this Article,

domestic medicine producer may produce
medicine not included in the national drug li st
and have it registered in a special circumslance
to sell it to foreign market.
No medicine that is not included in the national
;;1 "'I'Ili'm'9" n·lI,h,I.,,!? onJ!:;>'d' uullCl/C mNr drug list and not ha ving certificate of
YA·rll'l"r<;, I'oo)!:;>'z:)' 9"1/1'1 9"llhC registration may be supplied to market.
iD/.4-·"" I'II.tlm' au.~;>'I:)' lOY 1If!, lI.m'A
r,.e'l'A?":: 41 The Authority shall issue a certificate of
!iI 'I IIpA "l't· aot:;>U' lOY 1I.e )',}.Il.m'A registration of medicine market authorization
I'au!'-';>'d' 9"1/1'1 Y"llhC m/..p,), 1''''I.llmm':- afler:
U) rou)!:;>~:)' r,y"t·;r' 4,111,1] l'auAIJ9" a) assuring the medicine mnnufacturer's
r,au6-t.·)· Mt,C, 1',1'1\,/'11 nolf)' c'l.t.;J'I'r r
compliance to good manufacturing
II) l'1li au)!:;> 'd: !'-WI) ,). ! 'r Ir ..,.. " .. 'I' 7i) .j, practice;
I''''LY /. ;J"/m' fI)}!. 'f '/'19",,/aum' aull
b) the medicine dossier is evaluated and found
"C·n,'} Y",},II hlf)! ),,,
to fulfil safety, quality and efficacy ·
th) au!'-';>'d: I'/HI,H·,t. 'rlr')' ?"C OU 6' requirements; and
ooll .. C·j'·:jO·, .I'''J,I\ lit"" r
c) the medicine fulfil laboratory qllality test
requirements.
Iii "'I'}<;'m'?" n9"t-'f I'oo)!:;>'z:)'
!'au)':;>):)'
.?"'/I'I'1 ?"1l),C ml.oj> ·)' h'rflmm' 0'),1\
51 Any medicine manufacturer may change any
n?"1tl'1 m'P''''' Ollmm' aul,Jl I\.e "'I'1'i'0l-,}9"
information submitted during application for
'H', ).). tlm,'r liS j',C"1 I''''L :1'11/0' J'.UT/'
cenificate of registration of a medicine after
Mil p tI "l'I' (1)1'U,lj: n"'I 1\ 10 'P 'l 'r ./>'1 WI')'
issuance of the certificate only upon written
c'l..r1 '1 Y.(f 'l A ::
notification to and approval orthe Authority.
 •

- =- -
:';/ 41'rg:m·?" tmx:;"I'1:1· fflulJll'/O ),9"/,·:-", 61 Any manuracturer who h,,, 'l.OI re gistered
1'''''.1': yd· 9"'11'1'1 ?"IIIIC (IIt. ·I'·I:') (\"'I"Y.1l medicine shall submi t J!l application to the"
01.'1':0; 1,'HlI' inn
f'I'an(\Il'I'(II' 7.1~ Authority for the renewal 01' th" certificate of
1l'~I·n:I'·I' hll,e:10· mlr')' ot.,)· (\qt\/"tI rcgistrution of the merlicinc s ix mont hs before
(fl',· o'/an l.\h'J: ,"/+t.·11 t.I\O ')·:: the expiry o f the per iod stipulated under An iclc
13(3) of the Proclamat.ion.

Hi. OO~2'!:)' '} "'lll"'lf')' i "'WI'll') "'I11<1-t..:I. 16. Storage, Trans portation and Oistrihuiion of
fil "n'i'(IJ'9" fG",,~·;.l~,+ MOt·i'·, I\h.' Mc!lieiD~

Moor.T.l. (II g.?" AM. i.,!'. au!l.·;.l~.')·') II Any medicine manu factu rer, exporter, im p0l1er
O"'lJ'lI o H ·O.)-' OO~•.I':17·1IO')· ~') or distributor shall store, transport or distribute
O"~..PM· ',:t, 0')' 1.1~ O'/·10.m· fon·4")· medicine at appropriate temperature or cold
(1nrn~} mf.9" Nll.!1' lb 0',(\(\,)· m'll'!' chain.
UDlri idHl')'::
21 Any m~dicine manufacturer, exponer, im porter
~I "'l'g'm·?" ruo~;.l'd· 1,9"{.·:r·' 1\11, i or distributor may transport medicine by any
Movr.r., oJ,!',?" AM.i·,!', oD!I.·;.l~,')·'1 "'1'1'111 conveyance only where the compartment of the
1''''1. )'-(\m· /1(1\> !I.';.l'/.'t' :>C 'Ihll, f"'lS t.ID- conveyance that has li nk with the medicine has
f"'n'}~r II<;:tI ')O' U if';' OD~;.l't'~') been cle.aned to the extent Ihat chemical,
(\"'l'f'j'm, 9" /1,"'I,IWe r AIIl\'/? (1),!'.9" physical or microbiological contamination of
o'/.C',he.' III"(\-)'UIA 'Oh(\')' O"'l.l' ?A'!' the medicine is prevented.
UDAll· 00 If'! A(\O')'::

Xl. on~2'!.:).: 1.1I{1~Jl ')Il. M Moolln- M"'I-l-t.ll 17. Medicine Ad"lIcration and Counterfeiting

(if O"n'1m'9" OD~;.l'd· I\,!', ovm',·,}r ,l'.II-/"1 1/ It shall be prohibited to add or mix any foreign
(1),!'.9" . hllJ'.''',) f,ooq'fC I ootlh·'1 substance to any medicine so as to change its
(\"'I"ooC (1),e9" (\(\.1\ ',.oo"",!'. 'll\"'l (tll.:l.
amount, content or weight, or to make il appear
lIoY: ~lC ovGI;\,onC (1)/!.9" 004'I\4'tI
better or for any other similar purpose.
l"I'h(\lI(\ ~OJ'::
2/ It shall be prohibited to partially or completely
~I "'l1'i' ID- 19" aD Y:;.l'd· II"'1WID-9" 1'(lID-I
embed in any medicine anything harm ful to
mS '~:I-'l h"'l.ltl m,l?1" foo.~·;.li.. ~·1

.;. 'P7i'I')' (\ ..I''}~tI human health or that can affeci the quality,
11"1,:r..:I. )lC ?C 011&,.\9" if~ -fl· safety and efficacy of the medicine.
000'(\' ooJ',IlM· I'-/.ht\ht\ ~(1).::
3/ It shall be prohibiled to present any medicine as
i:/ "'l'g' aV19" f 00 !I.';} 'd' "'1'01..1' ' if it is produced by the real manufacturer by
I'T'lY: 9".:1.11')" f'}'7Y: 119"
imitating its package, identification, Irade mark,
O~'}'i'ID-'I9" 'l,!'.~,). Afo 9"tI)),)· Ooom4'9"
trade name or any special mark or present it by
oo$':;.l~.. " O),m·Hli'm· f,?"t·:r ),')J'.'/·oot.,,,
0"'1 il 00(1 tI (IJ J!. 9" I' 00 $':;.l i ..h ,). /!. II')' ') altering its content and nature.

'lU': flm (11 "'l~'l11 1'·/·ht\M ~(1).::

!~. oo~2'I:r (1).1'. Ale ID-il'!' M"'lIl1'l-r 18. Importation of Medicine
iii "'1'1'1(1)'9" (\m· 00.1'.:;)'1.'1' m.l'. A1C m·il'!' 11 Any person may import medicine upon
"'lMIl')' l''''I.1'(\ID- No$':oo "'IIl1Il.l' &.:/' J'.' obtaining pre-import permit and a penn it of
c'I,(lmm·') 000"10 ..1' h.I\ I\,I? hll(\/"A<I\'t-
entry from the Authority at a port of entry.
';':f>.~' (I.rn ,!',If,)(.I::

111 '1(\/,,(.1<1\1' hm·r.T.l. A1C \'00<1\ oo$':;.lH· 2/ The Authority shall calise the disposal or the
.f.U'}H;' '!'t-,~ ro,l?9" ';''P7i).~ .I'.:I.mn4' return to the country of origin of imported
IIlf~ A"J'lll '1i'\ar oo'11Y: ~, 'IP,,(1)l$': ro,!'.9" medicine, as may be appropriate, when its
roy. au<l\n-)' ~,lC h'J.'I,OD(\{) .l'M'.C:>(.I:: safety, quality or efficacy are not up to Ihe
standard.
 r~deral Ncgarit Gazette No. II 24lb January. 20 14 I'ilge 719}

rl '1(;l-"tI"J~' MNIYIP,Ol' cTD7:;>,d' OOD~'~ 31 The Authority shall issue appropriate evidence
~:), M 'Iftar {'em';' ·} n o/,HI jill&") ""'IllL:<l for the disposed medicine when req uested by
.eO"l.:', :: medicine importer.
Ill. MooY:;;>'I.'}- '1'':' hfr' t.'1 ""'I7i1J' 19. Raw Material and Pacldng of M('dicine

~I ""'11>;'(1)'9" (lOr ruoY:~'I.·l· '1'6. '1.:1''1 "'Ii'i1.Y II Any person may only produce. imp0l!, export.
"'I7"uM "'Irwo"I')' I ,,"''In I ""'IM·&":\ di stribute or store raw materio.!s and packagin g
01$'.7" ""'1)1"'1'(-')' I'"'I. :(. illD' Mill-" tlllJ'/, of medicine after obtaining permil from the'
6.:1'Y: rU'1'i j!./fr,I:\:: Authority.
~I '1l1l-"tI"I~' \' (/D!:,;)~:)' '1'6. 'I.:1'r, "'l7i1.Y 21 The Authority shall issue detailed directive
O"'l.""lIh')· IICIIC aDoot.j j(l)llJtI:: regarding raw material and packaging of .
medicine.
It. fAt"""10 uu~·2'1.,r Ol!: h1' orllT 11.111 20. Import orMedidne Not Registered
OO"'l.TMt !J:'l.;J'

IIl1l-"tlllJ~' h"'l.h'l'I\+ 7"h1Yf·i: On1~ 1'7"11'/'1 The AUlhority may, on anyone of the following
7"llhC OJ/.-I+ r .... ilm· UD1:;)~:)' OJ.". n1C OJ·Il'!' grounds, grant a special PCOllit for th(' import of
'1.111.11] tW 6.:1'1: 11.0'1' .f:', 'f"A:- medicine not registered :

Ii! ilihh9"'1 oo'hrr m.f:',9" il ...." I'\.e'l<,\'l? II for clinical trials or any other scientific
9"C9"C I investigation s; .

'1./ O,hh.9" I';r II 1111')' r"'ltl~(, OlU'}- "ilOl' 21 for personal use of a patient. when prescribed
-t-m:l''''l. "lIlMll by physician;
1:/ il7"'/l111 'FI"'I I'II·n~·r-t. '1't+ 7"Coot- 31 for conducting laboratory quality test for
1'1 "'III'IS: ! registration purpose;
§/ /\1'6.'I'C' m.f:',7" (1m· ot-7i n.".:J m.e7" 41 for natural or man-made disaster or similar
1'I'~aoM.e M'fl) ..e '1.11. oc.~;t·! emergency aid;
l;1 ilIl.1n- 07'I-/;11 "'l.1I.r·>1' ;...,A "In-t I ID.e7" 51 for use of diplomatic missions; or
'j,/ OMaor.tl.?''f ·)·h·/.')· 1''''l.ei'lllJ'for 61 for medicine lacking motivation of importers or
on!:';;>H':Y") (D,e7" IIi: "'·I!·/.,r ,\1\,/1- for medicine used for the treatment of diseases
07i;r?':f ;),119"'1 1''''I.orll· ao!:';;>'I.,r·1·J not given adequate attention.
II "'lll?IJ'h
fi~. ilOouCtlT'i Q.)./.t- M~'H: OU!:';?'l.tT 21. Poisons and Radioactive Pharmaceuticals
"'I'lli'm·7" (1m· hl]ilp'tlfT]~· 1'11:1")' "'l1..:J1""J.
No person may manufacture, import. export,
9"lll1C 01/''''')' I'\y'/,\, auCII:l") OJ!.'.9" 6t\,/..(r
>,<t:II4! oo!:,;)'!.+:),·') "'17"I..,}-l m!. MC orll'l' distribute, store or possess poisons or radioactive
"'IMllt I m!: Ol··t" oo"h 1 "'1M· t. A I "'Ih"'l'ft pharmaceuticals without obtaining a certificate of
my,9" uoj'll n.e'f·tl9":: competence from the Authority.
fill. ilOthh9"'I -ht- 22. Clinical Trial
fil "'I')';'or9" 0i'I0l' 1I.e I''''PI'l.7: I'thh9"r, II Clinical trial on human subjects may be
ao·ht- lI'1i'1l-" tlllJ'r 1''''I.t.4'!:or I'7"C9"<;' authorized by the Authority after the research
TC'T'IA hflj!,'){Jl hth"l'1 hp'~-7""lI]C proposal is being evaluated and accepted from
oJ'IC '~19""l'l" ""I'I]J!, ~.) . I'l.Yn j?lfr, tI:: scientific, legal and ethical perspectives.
III "'I')>;'or9" 'l'oot·"'It. OtI.U 1.')4'7,' 'l0·1l 21 Any researcher applying for authorization in
o'H7,' (Ii) aul'll. ')· 1..:1'Y: il"'l"l1')' o.m.er accordance with sub-article (I) of this Allicle
fll]l'IP'A"I'/, I'7"C7"~· J TC' TIIA 1. MlMr'1 shall submit to the Authority the research
'1-1]'11.. MIfH· lIt\an.y?,'): N ....1. aol..}ll proposal, relevant information about himself
I',MI9n 'l ao·ht· f"'l•.I'./.,,}II·)· (7O.l'.·~~:)" and his associates , the medicine for the trial,
hihh9"'1 on·ht· I' 1-"~-9"·II]C /l"'l:k I"~ilm permit from Clinical Trial Ethics Committee
6.:1'Y: '1.'1 fl.il·l· Mt.1\7. MF.:V) "'Irl.lI and other necessary documents.
Mil')' : :
 Fc.eeraJ Ncgarit Gazelle No. II 2·)'-" January,20 14 Page 7194
=
[I q(\ ..... J~.tTJ·,. t. )J>.'~.: \'011l0Jo'} 1';1>119"') OD·ht- 31 The Authority shall regulate the progress of an
Or?.ILar OouAlI?" I' (),h9",) OC~')' onIPI.1' authorized clinical trial regul arly in accordance
ou&.Otm·'} ,I',.p"Jmt-A I MtA?, if'> 0.1"-; with good medical procedure, suspend or stop
,!,'),~ h1.'1.*I.,!, 01.£.9" hVI,4I9" YJ.C;JtI i the clinical trial where necessary. ev"llIate the
1"1";')' (J>·f1kr.') f!.?CTD"I"'ItI 1,').'I,V·9" results and authorin' the usc ()f the result In

(\'i'O~,f'{lfl' 0"7.m~·9° V·'!.T MtI'''I(\'+ "y. such a way that it benents the pllblic,
h·)o'\.(I)·t\ Y,6.:PP,tI::

tir. I'mlll''''' -lit· ..... ~-9'''7IlC n°'l.1; -t-4'tTJtTJt 23. Clinical Trial Ethics Committee Sunervisorv
I'LlJI>\ Body

lif 1l(\..... tI tTJ~· r mh9",) -ht- ..... ~-9"'7IlC II The Authority shall establish a Clinical Trial
n"'l. t '1·.p(f]tTJt hll'" Y<J:"''''ItI:: Ethics Committees Supervisory Body.

f.! r ,'hh9",) oo·h/,· ..... ·'-9""/IlC

'f·.y.''ltTJt n"'l.· ~ 21 The Clinical Trial Ethics Commitlees
ht)(.\ nrY.L }~(J) · {'0W}.**(70. , .. tl,h9"" oo·ht· Supervisory Body shall be responsible for
..... ~-9"'7IJC It"'l.·f; ~1'1 )'(I).:p'l recogni zing and monitoring clinical trial ethics

,1'./1 'r""'!
10'\.1)09" M\&.'11. commitlees established at different leve ls and,
where necessary, for establishing them.
),10'\.<J:<J:uo· )'Y.C;JtI::

N rill)!?"') OD·ht· ..... ~-9"'7lJC I,"'/, t -t-4ItTJtTJt 31 The Director General of the Authority shall be
hlttl 0'11<'10. I'fJ(\ ..... t\tTJ'r- 'PC; P,,I',toHC the Chairperson of the Clin ical Trial Ethics
Commiltee Supervisory Body,

41 The Clinical Trial Elhics Committee

iiI I';hh9"'1 (7O·h&· ..... ·,-9"'7IlC n"'/,'~ N'tTJtTJl.
Superviso ry Body shall issue directive
hl'JA ?"t'~'I:')
(\UIl(l)tTJ')· f"'l.YIl:r·(\(J)o
necessary for discharging its responsibilities.
'tIC'HC uoool.Y Y(I)tTJtI::

til!. I'mhr", ov-ht- b1:?·l,(J)o ''It...:tET 24. Obligations of the Researcher

iii fmh9"'1 on'ht- 1\1:t-1.(I)' f9"C?"C II The researcher of the clinical trial may not
0:P 1.' "'I. Y (\'l(\ .....t\n]". <'IY<'I(J)o:PC; disseminate the result of the research without
Nq~· <'If!.~.I:':P "'IM·Q;\,r M'.';f·t.l9":: notifying to and getling approval from Ihe
Authority.

II fmh9"'1 ov-IIt- h1:t-1.(J)o 1l(\..... AtTJ'r- 21 The researcher of the clinicallrial shall have the
Oup ·llt-(J)o (\"'l.YJ.C1(1)· hrrtl fon·h
'1,1', duty to allow access to and cooperate with the
b-(I).'} (IT') (M·.T 1''''1/1'1'''0170., fon,,.1l0C Authority in inspecting the place of the trial
"1>1..;). MO'r:: and the trial documents,
EI hmh9"'1 ;JC 0'" NH h"'/,(I)tTJ
dO'lIt- 31 Except covering reasonable costs incurred in
,,.UDtTJ")"-; (l)Q,1. OIl"''''C I' ,'hh9"'1 ""'lit- the clinical trial, the researcher of clinical trial
11.1:'/'·1.(1)' 1',).tI?"') t7V·ht- (\°'1.;":'700)- il(l)' may not make any payment, in cash or in kind,
O'!'to niH] (l)J?,9" 0'},I'.~1' h<}:Y on&.~9" to the person subjeclto the clinical triaL
1I,1'.1··t\9"::
/'il:. m'!:r'l(Q=C'T I OIl'!'fl?J:fl llbltll ODI1l') 1lt\.I'.l.c'I 25. Clinical Trials on Pregnant Women, Nursing
r'l(J)o (I) g, 9" 0"'l1J ,n (!)oil'!' 1111 ~,}II 'I g, 1''''I..I'.l '7 Mothers, Minors or Foctus
I'mhjl"'i' -hb- Clinical trial on pregnant women, nursing mothers,
nl.'P~ H;(ii) nor'll·)· m<i:llm'C''f I
I.')"''''' minors or foctus may only be carried out in
Oll'!'o.~~f 1 1\11')(\ uonj'} '1A.1'.lr'l r'l(!)o (1),1'.9" accordance with Article 15(4) of the Proclamation
"'IIJ~ ') (l)Nr 'll\ )\")11 1),1', I' .1,h9"'1 dO·ht- upon ascertaining the fulfilment of the following
II.h'lw') 1''''1.1'11(1)' l''''l.h·foI\·-l· v·'!.:t· ~':): conditions:
dP"l"T'f(J)o t'l.l;J1'l' 1.'.If'lA:,

" . . ... "- '-" ,

 Feoeral Ncgaril Gazette No. ! 1 24th January,2014 PlIgc 7195
-
iiI auJ:;>~'I' n;h)I9"'1C1l' IICc,: 1",G~,)m·C'f'}' II scient ific evidence is produced proving Ihal the
n'l'fl. 7, '1·Y·l·} i M,I]n aom') YAY.!.II· medicinal product is intended to diagnose.
II?''.)'') my.'1" "'Iu:n arll'P Yfl )'011') ms
prevent or cure diseases in pregnant women,
llauovCm'C! fl71;t·'} nODMhA roJ!,'1"
nursing mothers, minors or foetus;
lI"'Ih9 U
r"'l.Lp. f!tiaotfi· t'lj?,')t'I'e onal
ou:"LfI' l

I;.! I' fhh9"'1 UD·ht-ro· h',c,:lIm·C'i··' hM'fl. 21 clinical trial carried on persons olher than
1.'11"1: r M,lJfI uum') IIA1.LII· fI?''!'· my.?" pregnant women, nursing mothers, minors or
"'IU?') arll'l' I,ll )1"}11 m·m fill· M"i' ItJ!, foetus cannot be expected to produce
I' "'I. m (H (I" ' j satisfactory test results according to scientific or
h') Y. "'I Y.fA medical knowledge;

el M,'l'fl. I.';'}' ,,)'. 1''''I.tJ'1.!1:: \','hh'1"<; on·/!tr 31 in the case of a clinical trial on nursing mother,
!l.tf') flm+ m·H· 1l"'l1]1~r m.l'. UlI',· the amount of medicine passing into breaSI milk
1''''I.1'lttl6.m· I'on.l'.·;)'!.:)- onm'} OUl\~' ItJ!, may not cause harm to (he breast fed infant;
1· ... ·)· rO~J'l'Ih')'A onln· :

iiI mc,:flm'C my.?" 111l'l'11. }.'l'}' '1Y, I'"Y.II'I..I'." 41 in the case of a clinical trial on a pregnant
I'fhh9°<; on·ht· !l.tf·) 1'lI'\,'hh9°'1 aD·ht-ro· woman or nursi ng mother, the informed consent

1M '1·.I'.C'IIt·)· hl>')fI· m)'.'1" hUlI~' 10'1')'
;JC I';J/r 1'1'1"9"1')' m.e9" I')\")(r mJ!,'1"
rUlI'7- M')' f\t\,tIn')· 0·'!.;1' r~"-:flm-;:::
my,'1" 1'10'1'1\. 1.<;;1: 1l'1"?"~')' on1'H 1
of the pregnant woman or nursing mother and
the father of the minor or the foetus or, in
absence of the latter, the consent of the pregnant
woman or nursing mother is obtained after
being briefed about the clinical trial;

?il 1110 11/'1 aum'} IJtlY.LfI tlJ':' Ity. fI"'I..I'.L"l 51 in the case of a clinical trial on minors;wilhout
I'fh h'1"'1 on. ht- (\.In rAil: 'l' ~ '1" prejud ice to the interest of the minor, the
'.1.1:1'100". If .. 1'1.<;.).'1 M." mJ!,'1" I."", informed consent of his father and molher or in
CP)'.?" M't. O"'l)'.':CO')· /1''1.;1' 1'1o'}... 'fm· absence or one. the informed consent of the
1'19"9°1'} m)'.9" m"J':' ytlJ fhn hlf1 other parent or in case of an orphan minor. ·the
rM ... tm· 1'19"'1"1'}' (7011'/: I infomled consent of his guardian is obtained;

~I 0"'1 I!l\ ') m·I'I'l' CJI\ }\"'}{) '1r, 1''''1,1] '1..1'." 61 in the case of a clinical trial on foetus, it is
r ,loh9"<; aD·lIt· !l.lf'} O)\")t\· 'I.e 1·...-l- confirmed thai the trial may not cause harm to
. 1''''I)'Y.CIl onlf'7-" 1'1.<;.).<;, M'" my,'1" M'" the foetus, and the informed consent of his
0"'1 )'. .. <.11·)· li·'!.;1' I'h ".t. 1'1'1"9"1')' on1'H;: molher and father or in absence of the latter, the
consent of his mother is obtained.

~~, ObbP"r:' ihuoP"1''l'x 11£ M"'I u., rihbp"'i . 26. Clinical Trial on Persons with Mental Disorder
~

111o'l'il: Io'H)\' n;'(ii) UD/PL')' I1loh9"C' Clinical trial on persons with mental disorder may
fhaD9"1''l',!·· 'I.e I' ,MI9"<;' au·llt- l''''I.h<;ro~(IJo only be carried out in accordance with Anicle 15(4)
l''''I.h'I'fI·.'f· II''!.;!'?''!'' aD"" 1I;1''fm· lI.L;J1'l' of the Proclamation upon ascenaining the fulfilment
r,lf'1 tI :- of Ihe following conditions:

'(;.I 1','hh'1"'1 uo'ht-ar <J.'1"'1 uo.l'.";>t." I'loh?VC' II the purpose of the clinical trial is to diagnose,
fhau9"') IIUDUOCUOC 1 fluuhlthA ' my,?" prevent or cure mental disorder;
fI"'Ih'1" 1''''I.m·tI uolf',·!
~I I'fhh9"'1' o"·ht·O)· hlo/,y·C' ,)\on'1""''l'~' 21 clinical trial carried on persons other than those
(Il'''V' I)t\. fI 7'':f- 'I y, 11.1J'I..I'." f"'l.t.t\1CD· ') with mental disorders cannot be expecte-d to
f(7U·ht· 01'1ll,')' "'IY""]')' h')Y.",?;ftl produce Silt is factory test results according to
"Y,')I\P, IOY,9" 1','hh9"" au':}l aD.ft:n·: 1.'1 scientific or medical knowledge; and

"""."
 -
Fl!d('rul Ncg:J.rit Gazette No. \1 2·1 '~ Janu:lry, ~ Q 14 Page 71 96
- - -- - - - - ---- ---,.-.-_., ------_.,- --- -
i'l fM,9"C' <t1CJ'D9""'';'W' t ..<J>.<;··) lluo"/M, 31 the informed consent of the person with mental
!""(fA hli"/ \' ,),!I?"<;' ""·ht.·IIl· ""IAY-II} disorJcr is obtai nt d if h(' is capJ bll.! to give his
flrr';-j: 0071·!: mfJ9° t..;I>p,. ' ) consent o r, where he is not c<lpab! c to give his
{]<I: ft }'.ln (I.·I·e V/,<'Vl(,(I)' consen t, the consent or his guardian is obtained
0077"':: afte r being br iefed about the cl i n i~al tria l.

?lX. Om"} ;I=?·"'i.P''f 'I.e M"lU"} fluil9"'! - M 27. Clinical Tri al on Prisoners

iii Oh'l';>; h'H7, i(i(!i) uov'I.:'· O;h'7 ;/'t.."'/. II C lini ca l trial on prisoners may only be carried

fig, 1',),))9"" """Ilt- 1''''1./'''(1)'/(1)' V"'!.lI out in accordance with Article 15(4) of the

-tl\.". !I·'!.;N"): 00 "J."!;Ffw· ttl.:>1'!' Proclamation upon a, ccrtaining th e fulfilment

g,lf<; t.I:- oflhe fo llowing condilion,:

a) the clini ca l Irial is to diagnose. prevent or

II) 1',),),9"<;' uo·II(.·(O· O'/'M, liMit··)· :>c
treat a disease th :lt may particularly affe ct
O·I·.!'.I'11 0,),,,/ ;I·/~"'I. P>""· fig, r"'l.hfl·)·
prisoners; and
Uuu9",) II I7OI7OC uuC ; lluoMhtl (Og.9"
fI"'Il!9" 1"1' •• 111 hlf) 1 ?,,, b) the prisoner pal1ici palin g in the clinical
trial can make decision whether to
(t) n,),II9"" ""'ht.·(1)- fig. r"'l.ft·htlD-
participate in the trial free of any undue
;I't.."'I. llooft·,·tj: nao·fI· )lI) ')' lI(I)II~::
influence.
~/ Ott. U ~, 'H)\' 1M! h '}oj'?' (Ii) uuv't.·)- Q,U"I
21 The concerned prison administration shall h~ve
t.." '/. 1If. f ,),119"<; "",·ht- Il.h<;w')
the righl 10 be made aware of. and have Ihe
r"'l.onflll·l·w, "'It."'!..!' Q.~' i.t,-t.<;Y.C
re spons ibility to provide Ihe necessary
/').<t.!'(IH·m· f uP Y.I. "J onl1'" ,"C"),
cooperation for, the conducting of clinica l trial
Ml •. fll(l)·'} ·)"O·OC r"~ !l: t. "J fI.{, ~ .,.
on a priso ner pursuanl to sub-articl e (I) of this
g,<;'CIl tI .. Article.
1ft. r mil9"'1 _lIt-1 M'!Jj:1. '!' 28. Withdrawal from Clinical Trial

r a,il9"'1 on·ht- ?,').<tq'L!l:n+ I'-t(l"'l"'l (1(1)0 Any person, who has given his consent for a clinical
0"'1<;'1'(1),9" 1.11. "",·ht.·(1)·1 "'I*I.'!' .ei··"t'.:: trial to be conducted on him. may wilhdraw from
the clinical trial at any lime.
9"ot-tj: Y'fI+
CHAPTER THREE
l'IIU''1'f'1 -t 1,,7?~ mg.9" h"'1t-'L" mil9"'1 TRADITIONAL AND COMPLEMENTARY

oo.l!:;?'!.+ M1'-'\Y,C" 4l'!''l'C OR ALTERNA TIVE MEDICINE

ADMINISTRATION AND CONTROL
t i!, M!l.IJ.I) If on !l:;?'!.+ 9"1/111
29. Registration orTr"dition.I Medicine
{if "'11>;'(1)'9" 11(1)0 I'I]Ut'. on!l:;'>'!.')·'}
II Any person may apply 10 Ihe Authority for Ihe
fI"'Ifluo'U111 llf\an!l:;'>'L'" 9"1'L"; I'hm.4>4'9"
registratio n of trad itional medicine by
11'),;1'<; i\1\.'-r- Mt."'/. uul.J\p'i·
submitting information with regard to the
Mil P'tllTl'1- O"'li·l.11 "'Ioot'.h·)· g.'f"t'.::
source and use of Ihe medicine and other
necessary information.
'1.1 <1f1p't'.ITJ~' 1'<10t'. 001.';'>'1.'''') .t'1'7i~')'1
21 The Authority shall issue certificate of
.f. u·})·)·c; 'I't. ..). 1l..I't.:>'7'I' 1'9"1/1<1 9"flilC
registration upon ascertaining the efficacy,
rol.4'·)' g.lIlTJtI::
safety and qua lity of the traditional medicine.
;:/ <11lP't'.ITJ'/· Otl.u ~,'H)I,' '}D·fI h14'l\' (ii)
31 The Authority shall ensure lhe confidentiality of
anllt.-)· 1''''I.·~CO· ·)·') UDI.}\P''f "'1.fI'!'t-'f~·'·
the information obtained in accordance with
ronm01> "lY.;/' MO')'::
sub-article (I ) of this Article.
q), '(1-Y,22&' (l)g.9" h°'lt-'L" mil?"" au!:';)'!,-r
30. Rcvistration of Complementary or Altrrnative
9"111<1 Medicine
Ollu Y.111 1114')\"
Ui(lI) MOD!l:OJ'!.·)· 9"1/1<1
The prov isi ons of Article 15(2) of this Regulation
r·~'.)l1(Ir ),·}Y.h"lQllH: r·~y';J;)&. rog.'I" stipulating on the registration of medicines shall,
h"'lt·"V' a,il9"'1 OO!l:;'>'!.1·') 1I"'1f1dD1I1'0 ·I't,lI"'/. mutatis mutandis, be applicable for registration of
~lf'1t:\:: complementary or alternati ve medicine.
------------------------------------------------
Feder;ll Negarit GalCtlc No. 11 241h JallU<.\ I)I. 20 14 Page 7197
- ~-- ...- -" 00:"' ~

CHAPTER FOUR
POST MARK ETING SI:RVF.ll.l.ANCF.,
FOOt) ANt) MEDICINE
SEIZURE ANt) DISPOSAL

31. Post M:lri{ctilH' Surveillance

/il 'III I'-" N'l',· 117iJ"1." n-l'L.n 9'''? ·n tJJ)',9"
au t: ;>~..). 'I.e .l:'lJL. 1n.r .p''j-). J'II '/.A6\ i 1/ 11,e Authority shall underlake post marketing
surveillance on food or medicine supplied for
n-/'1"iar tJJ·[fl.-)- oool'l'9" ·~1n. ro··}
sale, and based on the res ults, take necessary
""M.C·)· I'"'I S' "'J."t V'<;' fl. 1~ hC9u :q
measures against non compliance with the
J.',tJJil.<\6\ ::
relevant requirem ents.
f.1 "'I1'i'ar9" 1'9""/·n '~?:9n:_
21 Any food establishment shall have the duties to:
/I) 09""/'0 Y.U'li·)·<; 'l't,·)· ft$?, J'6\-!'mM a) inform the Authority where there is
'i''?C fl. ';'C t.'1I11'-"6\llj'/· l''''II'lro.p i unprecedented problem in food safety and
quality ;
II) Y.u-n,),'; 'I',H, J'6\'hnO'" "'1 -1';'(1)-')9"
b) refrain ITom distributin g unsafe and low
9"'7'0 h"'l {)t· (.I;\,,). I'oo,fm'(j l h<;
quality food for human consumption;
tI,) 117iJ''!.'' f1'L.Oor "'I')'i'or?U 9""1,0
1.U-}~.,,<; '1'&,,/, J'tlmn-/' hlf~ nauo c) collect and dispose, in accordance with the
1li'l11 'I () I'-" N'l~' 'I (lIlfJ or au oa t J' oao directive issued by thc Authority, the food,
L.')' l''''Iil(l)1.1:' i he offered for sale if it is found unsafe and
"IP..;J- MO')':: low quality,

rl "'IWor9" I'mS '1-:1:9":-

31 Any health institution shall have the duties to:
/I) Ooaj':;>~.-r ,]'t.-).! &.. 'P7\~'r<; !t.lm·r
a) reporl to the Authority on unprecedented
L~lY: fUTLP ,;J'1'ouro·'} il1rp;:(o·"}y'" ·/~Y.·'/P
adverse drug reaction, product safety
I'"'I J.',;t. (I) .p ':f. '7 C ! (lI;P 'f I' O'D !t.' '1.1- update or complaint on the safety, efficacy
0'DL.:<lP'1',,) roM n h')'16\':>)" 1''''I.'I'Cl1 and quality of medicine; and
:tt..;J- I\lll\I'-"tllfJ)' D71'l1D:t) h'J
1'1) '1111'-"t\lfJ'1' ou.l:';>'z.·~ l',l:u,)'11- 1
1'&..'1'7\'/1- 1DJ.',9" 1''1'601- "I""IC Mro, b) refrain from distributing any medicine that
1111- fl.J'I'l(ll ..p \'oa!t.';>'l.-I>·) ilC'!."-}- the Authority has notified as having safety,
1''''14'9"1 efficacy or quality defect.
'7P..;J- Mn'r::

QI "'I')'O'or9" 1'9"'711 ro$?,9" I'mS ,~*?

41 Any food establishment or health institution
'11'11'-"t\lfJ~' 1I"'I.J'tl 'U.ro' I'Y: vL. 10J' :t'H' shall coop,rate wilh the Authority in
l'oa·t-'10C '7P..;J- MO')':: undertaking post marketing surveillance,

51 Where the Auth ority orders the rccall of any

'(;1 1JI'II'-"t\lfJ'" Oll,v ;"H7, ')O,il ;")>/')1\ (i~)(t'I)
medicine in accordance with sub-arlicle (3)(b)
ooOL.')· 1';'') !t..,) tTD~:;)~.,)· I'-"C'!."·)· fl.Y'7!t.'
of this Arlicl., the medic ine manufacturer or its
l'auY:;>'l.·" ;'9"6ol- (liMn (l)lttl f-/'{)606tli-l,')
agent shall ha ve the duty to recall and dispose
oaY:;>'z.-l',i', ('uD{\NHI<; l''''Ii'lro1!t.' ;>ft'(''11- the med icine.
;'1'10')'::
6/ Any medicine manufac turer, importer or
distributor shall be respons ible to establish a
if "'I1>;'ro'9" 1'00 ,1:';>'1.')' ;'9"6oi'-! MoolXl,
pharmacovigilance system for continuously
1DJ.',9" ;'h'i-'i-J.', !t.'C:f.+ 1'10J' t.:I'!t.' '11"i0-l· monitoring the safety of the medicines for
oo!t.';>'z.1- f\J.', -t-tl;t-;J-J.', l'oo!t.';)'z.1- !t.v1~1- which it has obtained market authorization and
• 111-1-t\ 1''''I!t.'t."/ ~,<; "I'''IC fl.M1-9" to take corrective measures in case of
M&..ft1.(lI'1 hOTo.). IID?!t.'L."1 1'°'l.J'i'li'lIro,1 irregularities.
I''i-C'''II>n.:<l,ft 1il ilC'}'r ootlC .:>'), MO'r:,
 -
FI:(kral Ncg.:u ;t Ga7.c!tc N(1. 11 24!~ January. 201·\ Pugt.: 7198

1,! "'I'Fi'm'9" I'mS ~Iluo,y I''''IS ;>'l'uom" 71 Any health professional shall immediately
I'ffPJ~: :'~3' '1 ·lL Quty-'· "tv·?" \,uo).';;>'d· inform the Authority any adverse drug effect as
J.'P"li'f'!"j mf!,9~ '\'(r')") hiluoAI1-Y' we ll as problems that he encounters with
Y"'I.Y;;'1'"nt1l"j i"1C m.'\.Ym·'" tlIltl P'tV'l'r respect to the efficacy or quality of medicine.
"'l.\m7 (,,'In-)'::
32. Food or l\1(~dicinc Seizure and Oispo~al
~)~, 11''',/·0, ([J,e'}" "").';2):'1', MauJ'1t'i "'lllCD1i!:
II The appropriaTe organ may seize food or
iii 1I"I<1'n Yllm· "~I A '- medicine and order disposal or sending back to
IJ) 71ly <'I.e h '.'\.([J,tI Y tI'hlA Y. r the country of its origin where the food or
medicine:
II) MonMo l"I'lO l
,Il) \'(,7t1'1Il o ,) ' 7.1L([J· Yll&.:
a) does not have market aut horisation;

00) \''l'6'')' Y.l)1m·' I''''lY'''}/'oi b) is counterfeit;

tI') Ott.v n ·n uotl'l')' 1'11,1")· "'ll ;>7'"1. c) has expired;

1'"IlllC ml4+ Ot'l.lI()}o OiD' I"/'hon" d) is of deteriorated quality;
\"/'1,"·'(.11 [ liMA I'1'W rof!.1'" I':N.II :
rof!,1'" e) is stored, di stributed, alTered for dispensing
or dispensed by a person without certificate
l) IItI-U.4'.I'. 1''),111'"'1 oo·ht- 1''1'11:
of competence issued in accordance with
O"I:;>'I:h m,e l'" 1'"'71n nooJ'1/ h'Jl.m7Y.' this Regulation; or
(J)f!.?" ro.¥. (JD''1n')' ),7C h·),I\.ooM II.YY.C"I
.e:rlltl:: f) used in unauthorised clinical trial.

MI ,,"1'1'0 fllro· ill)tI OILU ",op)\,

,0·11 ",op)\, 21 The appropriate organ shall issue a certificate to
(Ii) 00 fit")· II -/'iD?Y. iD' I'" "111 ro f!, I'" the owner or possessor of the food or medicine
ooJ!:;}H' 09"''In· ro.e9" O"".f:;>'I.·" 'II'\/l.')' di sposed in accordance with sub-article (I) of
rof!.1'" 'ltlj!.,I;I' II.mr.'/> '''It.;>7'"1. I'"IlI1C this Article upon request.
(Ol4")' ,!',o "1 t'. ::
PART THREE
n'i:':" Y'M'
CONTROL OF TOBACCO PRODUCTS
1")'T''l1f 1I"I~r 4t'l''l'C
33, Requisite of Permit
@~, t,fJL1Ji1"'1lJM1:
No person may import, distribute or sell a tobacco
"'l'o;'(O.,9" \"r9"<11f 1I"IJr,.j. "'llloo"1r T
product except with the permit of the Authority
"'l h '\..!. t\ ro .e9" uo 7i'l' 1''''1.''11 (!)- 11"1;f.j:
upon confirmation of the product's compliance with
aull.!.C f· :r·,
"'l"'J. II·j: '1' t.;>"1 (TI hfJ liP' tI "1'1-
requirements .
.!.:I'I: f1"i II. If'' ~(!)-::
34. Protection of Minors from Tobacco Product
c!Ji!. lJII1J1'\
oum1 ftlY.lllll(!)- h 'r9"'I1f 11"1~r
Moumn.'/>
No perso n may directly or indirectly sell to or create
"'lW(!)-9" oro· 1")'II"~1f 9"Cf'1-' 04''l';I' ro.e9" temptation upon a minor to use tobacco products.
nTH,/,,/, t 11 111'1 unm1 IItlY.t.(, Il(!)- h lo'!.m</'I'"
un7i'l' ro.e9" uo71·1-·)· I"/'hf\hf\ ~(!)-::
35. Packaging and Labelling of Tobacco Product
@?i. MrP"fJ If 11"1'l':r "'li'iV'i 111 ~ )\'rrlj;
11 The labelling of any tobacco product shall
iii "'l,'i'm'l'" f-l'?"Qlf 1'''I~')' ?"C-)· 7'1'r' describe the characteristics of the product and
IW·<j: \'rl'"<1lf 11"1'f:~' 9"C'r <1Vt,T I'mS the health problem and hazard it causes, and
1-"IC "'lilh''''''' h'i 1I.~1'\H" f"'l.1AlI' If~' may not directly or indirectly create the
O</>'l';I' ro f!,9" O'''H'I''I't I'",~ frl'"lllf impression that it is less harmful tha n any other
1/"1'1':')' 9"C'r '/'.<;,). hM I"rl'"'llf 1/"1'1':')' tobacco products.
1''<;-}- y~1l uolf~" 1''''I.'ltI)\' uolf, I'IIO'r9"::
21 The label of any unit packet, package and
11.1 O?')'i'(J}'1'" l"r9"'llf 11"1J>:·)· ~m'l ;J'h.,r T outside packaging of tobacco products shall:
'l':r tI "'l7i1J''i 1'iD''r' "'l7iV' 1'1'r' l\' '" <j: , -
 -
Federal Ncgarit GazCtlc No_ !! 24~1 Janu ary. 2() 14 Page 7199

0) M,j'?"IlU' f'rn.c; Mh6.'1'l' Vm,Cj a) bear hea lth warni ng dc, cribing the harmful
"'Iilnj'}'H:,r \' ,I'll'; ,c',V?" (>n~i'i1 ,rm") effects of tobacco lise which slJall
1f,' (I) lluu,Y· wg.9" hll O'l,!'. 1''''I.i'ifi:,} ' constitute 30 % or more of the principal
display areas;

{lMA "'lfU.1l 'O(lG' \' A 'I! OJ ,!'.?" b) descr ibe the health wa rnin gs in .words or
,nC',',f/)-o1 Uan ?" yonfl]A m,!'.9" picture that smokin g causes cancer, cnrdiac
',M.'>:·"'/, f!. 'Il:'IA m.e9" (\.(\"1' 'l'?"Il!f') or bronchitis diseases or immature death or'
ooom','?" I''''l.oom- M:'I->;' I'mS serious health prob lems caused as a result
, '''Ie':)''') 1''''I:IA'iO I of tobacco use;

,,,) O,j·A·I,'1 '71:1''' If~' 1''''I.;rf!-'i 1''''OOfl c) be written in Amharic or English in large,
1,'; Y"'IJ?,t'I:P If';' Oh"'lC1 (flY.9" visible, legible and irremovable manner;
01,1''](\:111 \"1' 7. •• 1 1,'1 and

0 0) ,j'9"lJlf' I' ,rllm''}')'!'':: ~? C'1 Oal,o- OJ-l'l'!' d) contain infonnation on the maj or
r "'L ·f~(lJ·'} '1''1 'I'~' '; )0 '}'r.:: ~'IC 1'''1.? const ituents and main hazard ous
A)\' I constit uents fou nd in the emissions of the
tobacco products.
vall") hlln·)·;:
31 For the purposes of this Artic le, the term
tl IIllu n'}-r? ~1 •• 7.?9" "Ym·"l.b "'In1.f" "'I(\.j- "outside packaging 01 in relation to tobacco
1'1'9"lJlf' 11"lJ.'o·)· 9"C')' lI:rc;fc I''''I.'''C·OO·)· products applies to any packaging used in the
"'I1'i'(])'9" "'I'fi1.y ~ro·:: retail of the product.

~7i. "'I mil I' "'I.hII hM 'f (I}- .Jl2:. P'"f- 36. Places Prohibited for Smoking

iiI ,j'Y"'1I/") O"'l')'i'O)-9" ,M/fl O"'LllnllflOr II No person may smoke tobacco in a place for
(f>f!.9"" 0"1:IMtlll')' (1 :j' "'IGQ,{J t,AtlA ~cn· : : pub li c gathering or use.

~I .1,1/fl 1''''l.lIllllfln·j· (I>j?9" I''''I.'IMAO·)· (l;r 21 Places for public gathering or use shall include
1'''1.h·/'(\'')·') j?GQ,9" t·A:- the fo llowing:

/I) omS '1-*"'1')' h(I~A m-ll'r I a) rooms ofhealth institution;

II) O')-9"UC')' "'*"'1.). h<j:A (l}-Il'!'! b) class rooms of educational institution;

,,,) nUllfl "'I'l'l'trp':r· mNr I c) public conveyances;

on) h·)Y. If''M''':)~'1

MH'·t-,}f·:f 1](\. I'oot!" d) dining places like hotels and restaurants; and
1n.y (l;rP'1: i h'1 e) such other places prohibited for smoking.
as may be dctennined by the appropriate
u') l, "I'1·n .I'lIm· hIlA h ')-'I,eGtl.lIllr(l}-
organ.
1'''1.m{]'1rm· (\.(\":)' (l:}·p:>:r·::
31 Notwithstanding the provisions of sub·article
!'.I I'II.U h'H)\- 'iO.{] h'H)\' (ti) f:').n n. ~oC9"
( I) of this Article, smoking in places for public
n'1111-" tI fl]~. I' "'I.I'Ir. ;Il '//'0 I' "'l.1I n II fll] r (I}-
(]),e9" 1''''I.1I11M'l'·co, '1''.1:'''1.). (l}-1I'l' ')-9"1] gathering or use identified by the Authori!» may
[/") "'I Q;j, II I''''I.;J:(\(]). III /.(}. 'FI"'I n'MI' be allowed at a designated smoking areas.
1'°1r.tl,·!i (l;r j?tf'1t1::
I'A RT FOUR
,
hlj:tI Mo)'
HYGIENE, ENVIRONMENTAL HEALTH AND
n,g,l!. '}I I' hl-t'1n. illS nm lOT'1
f
COMMUNICABLE DISEASES CONTROL
1'.,.1\1\", n7i;rP'1"' 4l'l''!'C 37. Dangerous Chemical
(Ill. ilIIh1.1'i' h. "'!,lJ tI II The production, import, storage, transportation.
iiI "'I'}'i'(I}-9" ny.?'i' h."'I.' ltl 1I.001.:/- ' col'. n1C distribution, sale or use of any dangerous
arll'!' 11.11]' lI.h"'l:]'- ' 11.'1'111' 1I.h4.t.A ! chemical shall comply with the requirements set
117i)' ·1.~ 1I.1·C·fl my.?" MAoIII"')' 'I.e (I.m·A by the Authori!» to prevent any hazard to public
nu·OI.·/·(1) ms 'If!. 1'-'1')' h').'\N'.C{] health.
'1(\ I-" A f1) ', . I' "'I.)' OJ f1j(ll. ') OD (] t. C ,1, "'I "J. f] ·1·
MO')'::
 -
Federal NegarilGazctll! No. II 24!ti Jan uarY,2014 Page 7200

lU nll.1J h1n. 'IMI tI1</·?' (Ii) uo()t.·}· fro"Jar 21 In case of violation of the requirements
""f1"C·)· '1' '1'(1 ().1'>; h"ill·n filar hl]lI ,prescribed pursuan t to su b-article (I) of this
01.1>;' h."'Plt.·') {,uof11 0).£,9" h1nJ' Art kle, the approp ri ate organ mJY seize or
1,1.'U'llitHI )..e; )"1-'tGJ1.!!' (IJ.£,?" OJJ'.uo"JO'}· recall from market and orde r the disposal of the
hK )..',-'tonM! "'I.!!'t.'7 )..e; t\l't-i' M6.1\'I. dangerous chem ical or scndi'1g it bac-k to its
)..c?"P.~:f·'/ anar().!!' ,e.)'·'IlI:: country of origin and take other necessq,ry
measures.
(i);\:. rMh&.1 M'I11e; )..ro;n!l: 38. Transportation and Disposal of Dead Bodies
iii fjt'lJVAnl~- O"'l.f(IJ"J~:ro· uofl6.Cf·'f· uo()t.·)- 1/ It shall be prohibited to bring into the country
IIA·/'!.."'.I'. ntH-"'C Mh&"} ro.e.?" I.?'?" roY. or send abroad a dead body or human remains
h7C (IJ'f1'1' 1I"'1ft7I]·}· roJ?,?" hh'lC unless otherwise permitted in accordance with
1I"'1l1m fT l')' ilg.):A?":: the requirements set by the Authority.

~I ",,~C!I: 11.')' ')'0 ' 1'11 ro.£,9" 1."/1]'0 <lllro· ;11'7 21 No dead body may be exhumed before seven
uool')' {'on)"n<- (l;r lI.hl1{1 'I'-l'?" fl.t.II'7 yea rs from the date of burial except by the order
I]AIf~ nft-l--/'c Mh&.1·) h·I'."Ot.n·)· 'l.tl. of a court or where burial place is required for
:r:jI"C' (}f).). '}(70.). fI.£,·f.e, h·I'."nln,)- lI.ro"J public purpose in accordance with the relevant
n.l',)··AjI":: law.

1:1 flIl.lJ h'H?' ')0,11 h'}.,.l\· (Ii) f·I'Y.~11ar 31 The provisions of sub-article (I) of this Article
ohCh.I"(Ht rog,?" II'M1/?" f"'l.U"'I fl.?'?" may not be applicable with respect to the
"'I'l'l'ln 0"'1. un1111')' •hl. lI "'I. h J?,1f 1?": : transportation of human remains for
archaeological or tourism purpose.
<j)ii. r4li'ji'i hfJ'JI'i QJD~1.!!'

iii h"'llJ{I' filar hilA fI.e&.;PJ:' ouC~"'I flf'r 39. Wast. Handling and Disposal
(j)J?,jI" 07i;l' t'tfil'l·ftA9· r"'l.i·lI· 4I'ij'ij?,:-".,) II It shall be prohibited to burn or dispose by any
"'I:I'mA ro.£,?" Ot\ft "'I·)>;'ro·?" oul1Y: other means a poisonous or contagious wastes
"'IftlIl'/J': h,l',;J'A?n: : without obtaining permit from (he appropriate

~I O~'}:;:/iJ.?" oa~ nIJIIJVA"J~' froil1' organ.

onflt.Cf·:j'·'} n"'1":!.ft·)· h"'ll]{I IllIar hilA 21 No perso n may engage in recycling or disposal
6.:J'J:' flY1~ uoC'I"'I roJ?,?" n7i;r of poisonous or contagious wastes without
lI.fMftAIj: 1''''1.'f'A 4I'ij'!i1 ).. '}~ 1'i 'l'-l'?" obtaining permit from the appropriate organ
ft.£, 11"'1 'P A ro.e.?" n"'l fI ro1.!!' (tt- t't () "'I1r upon fulfilling requirements set by the
h.£,'f·(;\?": : Authority.

EI h'7lJ{I filar niiA 4I7i7i "'Iflro1P. ro.£,?"

)..1Y.'I'i 'No?" 'I.e, r"'I'PA t1lr f"'l.olrn'/' 3/ The appropriate organ shall, prior to the
(lr) hon(}\'uv· n~.·)· rf7i7im· n(l;rm' designation of a place for disposal or recycling
OVal·l.!!' ro.£,?" )"'}!'.1'i 'I'~'9n '1.1'. )..'}-'tarA of waste, confirm that the disposal or recycling
ov!'.l'7 nUllt.·I·()·n mS ftJ?, 1',11,')' of waste at such place may not cause damage to
h1.1'."'IfY.CfI "'Il.:>7'1' MO')' :: public health.

21 "'I1>;'ar9" .lAo 4'7i'ij roY. l,111]1l. fl.M';P

41 No person may discharge liquid waste to the
l'''n~ l'Iar h"ll]ll fllro· hltA r"'l.,l'ro"Jar1
environment unless treated in accordance with
Y.l;il t'tf":!.ft .£,lfe;A::
standards to be issued by the appropriate organ.

:1. fmS ~h 4l'l''l'C I'~l"ll]'far 1-*"'17-

40. Institutions Subject to Health Related Control
h"'l'1{1 fllro· hl'A m.'i ~h 4l'l''I'C r"'l.
y.l'7'1'l'ar '/-*"'1.). '/·11l.(]J·1 1''1,1',;1/, 1'i The appropri ate organ shall ensure that institutions
subject to health related control satisfy the necessaty
\' 1.111]0. In. e; hmI]O'} ouflt.C'}· "'1":1. 'I;r'l'ar')
hygienic and environmental health protections
fl.:>"'I"JA i Mt.'I'l.ro·1 I.C?")! J?,roflP,lI::
requirements and take necessary measures thereof.

~ -.
 Federal Negarit Gazette No. 11 24th January, 2014 Page 7201
-
!'i/i, f1:'I"'1;e; J:,M'J; '!1i,II'f._ 141. Sound and Air Pollution
"'1'}'i'iD'7" om' fjo'lr('\rTJ~' fUl1L"'01I 1I1.'i"} Any person shall comply with the requirements for
lloomn~' l'I,tI \',(79")\''1 I'h\'C '(JIJ(t,)-,) (tuDMhtl the prevention of sound and air pollulion set by Ihe
l''''1.yrorTJ'fro,'} oull&,Cf,:j" "'111tlC MIl'l':: Authority for the protection of public health.
!'ill, ffh]l1 CD/MY onM:<l 11'f. 42. Toilet of Pu blic Facility
"'11'i'oH" \';h'Hl1 tID7MY oo)VPl (1.'(' Any toilet of a public facility shall fulfil the
'lllr tI rTJ'f. Yro fl l'fro'1 oDIl&'C f':Y' "'1":1,1\'(' requirements set by the Authority,
MO'('::
!'iC. f'ill'l" Mtt: OD'}7r.7t'f lYl'fj'f. 43. Vaccination of International Passengers
/il 1''lII'I'' h~''f: oo'>?J'."!'): 1l'(''l,H f"'1.l'Im"(· II Vaccination of international passengers shall be
'lllrtlrTJ~' O"'1.f'II.',"'1'for 1'111.'1 'ht:"'1'(' given at health institutions designated by the
.r,lfe; tI:: Authority,
'1.1 Oh'l')\: h')1')I, i'lZ(li) anol')' ror. h?C or!!'!' 21 Any conveyance operator who has brought a
h'}.~,I'.·FI
1'""'I.;J'7f!: Oo"'} yavrTJ "'1'}:;'or'l" person not allowed to enter into the country in
M'l"ir f;J·?.r.m·'} (UD· f4',I'.;1-m·') mr.r.\, accordance with Article 26(2) of the
Oooo&. '} my. oofl]O,). h?C \,oooot'\ll '1>'..;1- Proclamation shall be obliged to return the
,I'.<;'CO;J·tI: : person to the countty of his departure covering
the expenses of his stay,
!j/i. Ooo"lo.Y'i' ODor"', 11.'\ 1''''1'l'l'JfE:f'i' .... ~.y.:f 44. Conveyance and Consignments Control at
",,'I"l'C Frontier Port
(il "'1'}~~llF9" IliD·"!.'· OJ),. ~,7C
1''''1.7'1 ro,l'.'I" II Any conveyance entering into or transiting Ihe
Oh7C roNr MC{Il I''''1.YtI'f: "'1'l'l'lf country may not bring or dump any waste or
OId'\"I\'Y y"'HlC htlt\. orll'!' "'11'i'or')9" remains of waste in Ethiopian territory except
ol'7i'1i m),',9" N'Ii''i 1/:1'.... h"'1.&..,.1:1'1'(·
in accordance with accepted manner.
Mt·c OJ'r.r.\, "'1111'1')' roM" ODrTJt\
I'I'IO·)·?"::
fl I'tLU h').,.l\· ')0·11 h')"')\, (Ii) rn.n o.~"C9" 21 Notwithstanding the provision of sub-article (I)
"'1'}'i'or9" 110" h')y'?" '!':r9" 'I),'. 1''''1.ort\. of this Article. any person may import
4'i'ii'i iD),'.9" ·/·L&. 9"C'(''} 'll'lrtlrTJ'f.') recyclable waste or by-product upon the
0"'111&."'1: my. h7C m·1l1' "'111'1'1'(' ),'.:r·'ItI:: permission of the Authority,
rl "'1')'i'ro'9" ,/'1\11&. OO;J' YM·IIt\4.tI ,/,,011- 31 If any conveyance or consignment entering or
1''''1.mLmC In. mM" mr.r.\, "'1'l'l'lf mJ'.9" leaving the country is suspected of transmitting
6J}'~.). mY. I,'IC 1""I:I'lor m,l'.9" h,,?C communicable disease, it shall enter or leave
I'"'I.m rTJ or C 6J}'.). '; GL1. 9" C· ./.? n. 0" fillS the country after undergoing the necessary
hlll'lOT 4l'l''!'C ,/·r.O"n-)· n'lllrt\rTJ~' sanitization including spraying and permit from
&':I'y.' fl.J'71 ,l'.lf'itl:: the Authority.

iiI Y.'I'" 1'J'.9" orll1.,Hi I'oor hlJ'If·:Y·i 0'1'1' 41 Importing or exporting blood. blood products,
m.r,'I" 'if!.~ 9 1:C u
my. MC m'Il'r "'1111'1'(' human tissue or organ, urine or stool may only
rof!.9" hh7C "'1llmrTJ-l- 1''''1.rt\m· tl'lt\r be allowed by obtaining permit from the
tI fll~' {f. t . .,. J'.' '/OJ':: AUlharily.

(if "'1')'i'or9" m.r. h'IC m'Il'!' ),'Mf!.1'l 1';1-1Y:)
6J}'~'(' OJ),',9" 4'7ii'i my. ,,?C YIl'I'l \''''1;I'l'lf
h')"'<'I:I'O nt· ...·'i' O'll'l')11L'~ OJGT.!.
uurTJn')' "IC !'oDapI'I1l '1.r.;1- Mln-)'::
!'if;. 1:,}OC') Oh'1C M"'1.N:C01' '1<'1t\(l:f
mLCo"i'i' f!:')?'/''i' I' u·nL·/· ... l1 illS hr.:>
o"'1.hM·n·(· ·1.lb nh'1C ."':'wc· M:C(ll 1''''1.OJrTJ
OJf!,9" 1''''1.1'1 "'1'):;'01'9" "'01'
nav'1n.Y'i' avm·"'.
hA 'I),'. \'mS hlll'IO'''' ·/:'!"rc f}),'.J'.L "10')''1
f}),'.&..,. y.'I'I.). oD"]'1')' my,?" avm·'Tj·)· h),'.:r·t\.9"::
51 Any conveyance operator who has brought a
consignment not allowed to enter the country or
waste shall be obliged to return same to the
my.
country of shipment at his own and the owner's
cost.
45. Individuals Crossing Boarder on Foot
Any person entering or leaving the country on foot
at the time of epidemic and public health emergency
may not enter or leave the country without
undergoing health inspection and obtaining
permission at a frontier port.
 Federal Negari r G,IlI:U,' No. 1\ 24 \~ Jan uary , 20 l ,1 Pag,· n02

46. Sus pertcd Person a nd Dnl,. to Re po rt

iiI O?'j>;'m·9" mY. ~ 7C

1'0?1Q 'tMo ~"'Oj: 11 An)' internatio nal entry passenge r shall be
•
au 'j1.1'.~' fU ·OL·'·I'\n·') m,'J l\<fOmO'} f\.qt\ obliged to respond to quaranti ne inspection
t\I) ./,. '}-I;') 1:'I"1'C n:1>t1 my.?" OJ\' fr Oj: through verbal o r writte n request fo r protection
of pub Iic health,

!II OW rot·}· 0?'}>;<(D'9° "''1'1&, o'li;t- Mn1· 21 In the cOllrse of trave l, if an)' passen'ger is
'1'1111- 1""I.mLmC no'}?Y.>;' (I,';'C 1'00'l'l'lf suspected to be infected with any
~'}"''':J>i'i· n~tl,· n.J'lD- 'IfllD- ro}.'.9" comm unicable diseas e, the conveyance operator
1l'''I.J'cr,:nl \',,"'70S'; aU(D'''''L I~" ;.'1116. shall infor m the head o f the nearest or
f07i;I-(J)") 't}.'.~')''J 'P'J 'P'I 9°t\hf'1' destination rrontier port about the type of the
h VUh'" ~fto1' M ,VI7. 011 LP')7':'h o~"ro~' disease, principal symptoms and an y other
j.',<;'cn:rt\:: relevant information.

L'I OIlU ~')"')\, ')0,11 ~')4'j\' (Ii) ootlL'}' 0001 3/ The head o f the fTontier port receiving
I' .I'. LtI(I]· f 00"10 ..1''0 oom-""l hll ;)'It, Ohll(ll- information in acco rdance with sub article (2)
fI"'l.7~ 'H"'l"lt oolP.ro·'} (iJ.ll.J'lD-'" tTC')' of this Article shall immediately report the
O?.I': l"l ~(;n-} . :: in formatio n to the inspector at the port.

!il (II\'U A'H?· ~&.l\?'9" "l'oo"lfU''O aulD-"'/. h/I 4/ For the purpose of this Article "head of rrontier
;)'It." O? II ,). I' hll (Il- Mi !(. 7i'} ro }.'. 9" port" means the head of the rronti cr' port
aviati on or Reve nue and Customs Authority
1'10.)7'')'''0 '/·9"<· h qllp't\"l,} ''In.J' ;)'It.
station.
~lD- ::
47. Quarantine and Isola tion
!'ii. '.!.t-H" MO?1:l."I'O I\&.f. M"'I4IfT
11 Suspected person shall be quarantined
,iiI "'I')>"lD-9" I"rmlml tllD- ro.ll.J'lD-~ tJ.t·,}-I;') immediate ly. The Authority shall immediately
uo.l'.l."1 MO')' :: qflP't\"l'r I',rml.ml. (H"',)
send th e suspected person to the public health
f).t·'It'} ' h').ll.J'.I'.C?lD- flU'OL'rtl'O tn.'! emerge ncy management body for quarant ine .
.1'," 17'1'>;' ~,Y,;J , 4:'I"rC Atlt\ (I).ll.J'lD-~'
.rIl'''"M.t.\ ::
21 The Authority shall ensure that any suspected
~I 'l(lP'tI"l~' 0?'}>;'lD-9" f).t· 'H ') NY..l1 (1(1). person upon confirmati on of his infection be
0'1'''"&. 07i;J' on,fll' (Lt.;J?'!' roJ: tn.'J "''1:9'' transferred to an isolation room in a health
(If!,f, 0?<f>J' h~:t\ au'lro? ,}'J M&lI'l.lD-') instirution and provided with the necessary
fl. (J)oll 'J curative and rehabilitative treatment.
J'l. ;J "I ''It. ::
3/ The public heal th emergency management body
;:1 fulll. ,t-MI filS Y..',}1'/'>;' ~J'.;J ',:,!,,!,C ~lJtI shall organize quarantine centres in the main
O'P'J 'P'O au"ln.J''J aulD,"'/. 11C':f I't).t-'H;,) rronti er ports or designate the nearest health
" A7t\"Ifto')· ooll"'/. "~ah'l1' '} "'I.I'.t...Y,.) . roM" instirutions as isolation centres,
O~tllJn.lD- 1'°'L1~ tn.'O ''''II9",} (I}.'.'Y· "'I4IJ'
"'Iaht. AY..'C'l oul'll'9" MO'r::
48. Measures taken to Control Communicable '
'$. .,.",,'" 07l;t-)7' To ') Diseases
hC9";Q)7'r
II The Authority may take the following measures
iiI 1J(lP'tI"l ~ ''''I''':. n7i;1')7'1' '} lIori4l"lmC:- to control communicable disease:
U) T9"Ue')' f1..f.'l',}'J I\.(lo:f ;"1/11 aj ordering the closure of schools and other
1''''I,MMIIJ'f(])·'} .,..,/:0'/,), 1I'/'OlM 1.1b public p laces for a certain peri od;
11,11:) i
bj establishing temporary controlling posts in
II) 'I.ILJ''e 1'4:'!''!'C ''In..!' )7':f'} 0\")->;""'9"
any part of the country; and
1'~1t ,~ hOj:t\ II,N:4:9" I h'O

cj taking any other necessary measure s.

"') l1.li-1' Mt/ll. hcrJi)7'1''} fI.IDN': I
y.'f-'lt.::
 Federal Ncgarit Gazette 1\n II 241h January,2014 Page 7203

~I r"'l.onllh.~-:I'm· 71 11''')' p'an"ln ..r,;, unm-o"l.i 2/ Th~ relevRnt bodies shall cooperate 'with the
hAP''f' ~Y, 'llvvAfT]',· N"J..rs.C'/(!l· r-/'<,\fj6, I Authority at frontier ports to effectively
07i)'p'i' 1:'P'PC \'av'!-QilC "l?;i- M~:for:: I undertake control of communicable diseases.

11'i:;:-' h9"ll·j- I PART FIVE

rIP.';' 111l!J[l, HEALTH CARE

9" at· <;: Ii '}1: CHAPTER ONE

IlI\m,';' tr1l11[], h?A"I(\-1-- HEALTH CARE SERVICE

!'ill. 1ltt"'lllh1'l1 "I?,J-p"'h' rh:f.hg"iVh.1:1l 9"trc 49. Vaccination Obligation and HlV/AIDS
h1Aj(t:1-- Counselling Service

ji/ "'I'},;'or9" I'm,';' 'r,!;9"';' n''',!;m>- (!l'Il,}, II Any health institution and health professional
,/-,~'}'c: 1''''1.[1'6· \' m,'; 'lflov,y I' fhf,9"';' employed by the institution shall, based on the
.I'_l:<ior·) ",;, \,°UllnaV) h1A"I(\-')- auIPl')- medical standard and the service provided, have
O"'l~·l·' fl',',:fl m·c fI,-f.'f- ",;, fl"';"Y'1' the obligation to give vaccination and access to
l'auh'lhY l1,).(l-f.'f.'} "'}.Il.(llIlJl. ",;, HIV I AIDS counselling service to maternal and
1'h.'f.. hY,.'I1jr.,.I':il f9"trC h1A"l(\-')- pregnant women,
,,'I-'t)'71' 'rI.:'· r"91:l"l "I?;f' Mn'!':: 21 Parents or guardians shall have the obligation to
Vi (ll",l!'l' (llU" M"l'l.P'1' lIP}>;')e; Y,U') ~')11 vaccinate children in accordance with the
t'I"'1Il6.7.Y~ O"'l.(llfT]or ooautY aunl.')· directive to be issued for the implementation of
thW')") r"'lllh'f'l1 ?f\&,~')' M(Ffor:: the Proclamation and this Regulation,

2. I'm'" hm'lO:t "'-9"uC1-- 50. Health Education

"'I')'i'or9" ''''1:9'' !,"'I.(\(fl(l}-') MA"Ifl")'

I'm,'; Any health institution shall, based on the services
aut'll')' O"'l1:l"l I'm.';' hm'l/l<P 1--9"VC-f'1'';' provided by it, have the obligation to provide health
OJq.;r'/? aut.'P,7''''' M'1A,~I''f' r""Il(fl')- "I?:i' education and current infonnation to clients.
MO')'::

!Iii. l't..or{J'l 1'1''11:(1 thh9"'l h1A"Itr+. 51. Curative and Rehabilitative Medical Service

iii "'I'Fi'OJ'9" l'an,}"IIl'r I'mS '/-<}:9" II governmental health institution shall provide
h1A "11'1 • ..,. gollmr 1''''I.1'fl&· medical service in accordance with the referral
MfT]'}' q.l1·ntl·7j I-"C'H'}e; l"hl;'<7»") hq.9" system and its capacity.
'l1e;tlO auAIl· !,-Ife; A::

!{I I'fhh?Ue; h1"""/0-:" h·''111 Yoor htlA 21 Medical service may be provided at a health
O"'l.YrofT](I}- .r.t.:<i annt.-)· OmS 1'<}:9'" institution, at a work place, at the patient's
01-" t\- (I;f'1 O;f'lJ"'I.m· <70'0 tY [l,'r! h~;J home, at the place of accident. in an ambulance
01'h01'O')- I-"'i:t\- 1 Oh9"O'f\'}1l (ll.{J'}' CDJ?,9" or at any other similar place according to the
nfl.(\-:r· auoA (I;f'7''''' flo'}' .I',:y.f\A:: standards to be issued by the appropriate organ,

21. l';tiJ"'I.or1 m>-fr J.:j:1: M"'I"I"i1-- 52. Patient's Informed Consent

fill' ;f'11 "'I. (I)- 0"1')'1(1, 'I J?, I''f' on IP t. ,,, t.:I' .r: II Medical service may not be provided without
<'I,e'/"i I' ,MI?"'; ("I (~ '7fl·')· "ullin} r'/-Mhfl obtaining the patient's informed consent.
~(I)-: :

21 Notwithstanding .the provision of sub-article (I)

II fillIJ Ii 'HlI' ')0·11 h 'N')\, (fi) 1'-1'.1'.m(l}-
of this Article, medical service may be provided
n.'i'C9" O"'l.h,f·fl..)· "''l.;f' 7''1'' I' ;NI"'I.or
to a patient without obtaining his consent when:
t.:I'.r: <'Iy,n I'fhh?O';' h1Ct."I(\-·)· auillwr
J'.!i''1A :-
 •

Federal NcgaritGazclfc No. 11 24 110 January,20 14 Page 7204

--~-
0) ;HI"'l(J}- 6,.4>1: ouilm'}' r"'l~"fA a) the patient is unable to give his consent and
n. If 1'1 &..4>"~ 11"'1,11'/"11+ On VI. such consent is given by:
j"/'{lm n.lfl:-
(I) a person authorized by the patient 'in
(ii) ;Nt"'l,m- Ol\" !I''i': &. .9>-'\.") }.'M.1'l
writing to give consent on his behalf;
1'1\-)- OWhI'\(J}- (W)'l

(~) 6.:P1: lIaollm'} (J}-htl<; I"f"(lmm- (2) in the absence of a person authorized
liar l1f1.lI fl;HI"'lar I"/'-'\C '\1.>;' i to give such consent, th~ spouse.
A:e:! wI\:e: T WI!!: V" WJ'-V" }.u'l-! child, parent, brother or sister of the
w~9· patient;or
(n OU") CJJJ',9u O~c.(" ')-(\'111
o.'}' (3) a person authorized to give such
•• :P.I!.' }.')ltil1' ilt\"l1 ONlmar consent in accordance with the law or
flm-l
a court order;
lI) lI;J-I) "'I.m· ihh9"<; Mouilm')' 11<j:'/"lj'
b) failure to treat the patient, may result in a
I'U1U.·,·il·O mS nY.;J 1''''l'lIhh'l If~·
il.11l serious risk to public health;

,II) ;I-llo~,or o"}tll\" OJ~V" O"'l'}lj'arV" c) the patient has not expressly or in any other
ont\h- I' ,hhV"<; Mt\ "}f\o.p') }'11. "'I way refused to get the medical service and
J'-&'.'1"} ',,'I<'\OJ"'<; MIll" <; or 1 "'III''If .}.
any delay in the provision of medical
0;1'1]"'1.0)' m.I'I'} II~ 111\<1: '1--,\,).
service could result in irreversible damage
I''''IJ'ilh')·t. n.lfl::
on his health.
el "'I')lj'OJ'V" I'mS '11100', I';t'l) "'I.or') O"}'}1J1l.
31 Any health professional shall make
IIJ'- I"/"ouu'l'/' &.:P!!: 1I"'1"}·'i-}· '/"1Ilarl
reasonable effort to obtain the patient's
1'l'} "'IY:l"} MM·;:
informed consent.
§I .,j'-'\.'} "·m J'-.f' ,1l[IV"o;(Il"} nllUD t.M·1
41 The health professional shall explain to the
MI\O ;JoI,"'I. I'm.'; 'IliaD. fOJ· 9"Il;t'or
patient who refused to get medical service.
OmScll' IIJ'- ilt'I"'lf{lh""I\o)· W'IIb"" 1A?I\""
Ihe possible risks of his refusal 011 his hcallh
.eUl~· Iloo·<j; "'lil-~uo1' .ec;-c n;t't.::
and shall record same in writing.
?if Ott,u nl-"Y.· gOlPl:'· (1-/-1)°'l.W· OJJ!,V" O/V\
51 A consent given under this Article shall be
Y'M'';' (1)11 l''''lf'l1' &.iP!!: "'11 I'I.rIA
valid when it is obtained tram the patient or
I''''l ~:I\w' f'j-(Ilil',' I' ,),hV"<; '}J'- ~ ·Y."fl
any other third party in writing, unless it is
n"'loollh'} OiPt\ m.eV" OY:C'l.T }'I-'1.f'l1' permitted by directives to be expressed orally
nonooty I]t\,t-•• -~J'. nil,t-.,.c ny.·th·<j; 1'·t-1Illl or through conduct with respect to specific
(L1f') ~(/}.:: types of medical services.

2C. fY:l1H' ,r,IlV"C; .

53. Emervenev Medical Service
iii "'I')';'clI-9· I'mS fUJ'-OJ·)·
''''1:9" nY:'}
Y:'l''''''j' !"hll?°o; n1t\"}I\" )' I'ooilm')' "}i!.;t'
If Any health inst itution shall have the '
MO')';: obligation to provide life saving emergency
treatment.
~I "'I')lj'm-V" I'mS ,/"!!:V" Ollb<; .t-!!:"'I'}' 1.l1l
oulll'}' 1''''I.mON1·)·') r Y:')H'i' l'ih)]V"<; 2/ Any health institution shall have the
?'1A"}I\")' I'ooilm')' "}i!.;J- MO')':: obligation to provide emergency medical
treatment in accordance with applicable
standards of health institutions.
;:1 j'.t:''}?'/'r,' ;h)19"~'hC-'\;I' >.'7'111 lJl]:f(/}· 3/ Emergency medical treatment may be provided
n'III '" ;JC nunlf') hY.;J<; (lllC7i1 O·t-hll,t-O'} in all emergency and epidemic cites in
(1;1' !I·Il· uD{lrn')' .l'.;fllt.:: collaboration with lhe relevant organs.

. Federal Ncgarit Gazette No_ II 24th January. 2014
!I!i. I'mll?"" M." l'l' o/·1l11t't> TI. p'c'}t
iiI ""')>;'01'9" \' illS ."'~9" 1-. "i'l1l fllro· ;'llA
O"'l.J'IV"lro· \' ;'1A "ill- ')' ;.(I"l'!' .l'.a
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111'100 1'11. \''''It.;>1'!' "l9.;f· MO'r::
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ot.<j":·)·" rncJ': !D'<'I~> I
-
Page 720S
=
54. Referral System
Ii Any health institution shall have the obligation
to provide medical services :n accordance with
health service standard to be iss ued by the
appropriate organ.
21 Where any health institution is unable to provide
the proper examination or treatment to a patient,
it shall refer the patient to the appropriate health
institution where he can get the proper service in
accordance with the referral system.
31 Any health institution shall have the obligation
to admit a patient sent to it in accordance with
the referral system and give fced back to the
sending health institution.
41 The referring health institution shall, before
referring a patient for emergency treatment,
have the obligation to make sure that the
receiving health institution can admit the
patient .
. 51 Any person shall have the obligation to observe
the directive on the implementation of referral
system.
55. Death and Post-Mortem Examination
1/ Death shall be ascertained :-vhen there is no sign
of life as approved by a competent health
professional based on examination of functions
of brain, heart and breathing organs.
21 Post-mortem examination may be conducted
only where the spouse, child, who attains
majority age, parent or guardian of the deceased
or the appropriate organ requests to know the
calise of death.
3/ Examination to detennine cause of death may
be carried out by a competent health institution.
41 Notwithstanding the provisions of sub·article
(2) of this Article post mortem examination for
education or research purposes may be carried
out where the deceased has given his written
consent during his lifetime or where the
deceased has not prohibited such donation
during his lifetime and the consent of his family
has been obtained.
56. Medical Certificate
Every healt h institution shall issue medical
certificate to a patient containing the following
infonnation:
I I naI11e, age and address of the patient;
21 examination result and medical treatment
provided to the patient and, as the case may be,
sick leave and board decision;
 •

Feder;:!l Ncgallt G.rlClte No. I I 24 01, January, 201-4

J
Page 7206
=
1:1 \' ,MI?"'; "'1(,0:(1)' \"1' (\11\0')") 'I"ll 3/ date of the issuance orthe med ical t.:'ertificatc;

!if ·1·t1;J' ;!';', ",),7"'0 MU?M,t'l" '~' f;i'lI"'l,tD·') 41 whet her periodic medical treatment is nccc~sary
O)~';/,T fmS IFI.;/' I 'he; and the patient's current s ituation; and

<il fl.t'l- i" hflt,/I?, \'If'I' uul)lp-'i',,):: 51 other necessary information .

n. (\M~M:-'1L3''I'Al',~\ h?"e;
57 Artificial Reproduction ,
1/ Artiftc il1 l reproduction service may be provided
/il ,,'711'11 J'I\III' ,,1 '61 t,:J',~'
OO'I.f\1I1tD· \. inS
by a health institlltiOl; and health professional
'hl;?" 'he; inS Ilt'lUD'Y (lm' f\t·7i \"/,'Ptlf,
authori zed by the appropriate organ.
a,ll?"" uofllll')' .\";':"61::
21 letting or hiring of womb I(>r the purpose of
~I f\m, (It:1i " ''I'tlf. t'lu~I"U: "'IUO') "'Iht,
artifi cial reproduction shall be prohibited.
\")'9" In ",,11';·\")' f·/'hfIhfI ~m.::
31 No person or research instilute may engage in
i:1 ',,/')'1'(1)'9" (llll' (oY,9" f7"C7"C '/'<;1:9" f\(!l-') the tec hnology of cloning of hum an being.
m:r."'"T'j ';"ll{:'il"n :fI)\):mC /I f,:}'·t\9 1J
::

CHAPTER TWO
j1°M-50i:1'l-1' 'DONATION OF BLOOD AND BLOOD
()M.e'j'}'..~...:I~'I'r_ nL~.b!:ItLb.~E'i PRODUCTS AND DONATION AND
I'UlIl-U'P<\-r A1<\e; 1:"1\ -t-hI\ TRANSPLANTA TION OF ORGANS AND
TISSUES

~I 1'1.7"'0 \'.1'.7" "''PM, tl1<'1 i "'IMl'\lI'O .56. Donation of Blood and Blood Products
I'P'C"lC" )' P't·flJi' 00llq'f~')' OOClfP-'1·· II Blood and blood produCIS donation, collcction
'If!., ,~uuftC ,/'tD· aoh'OtD') 1.1\1l;fCf~:: and distribution shall be done based on
principles of humanity.
r.1 \'c'\(!l- Ilf!.,Cfl')·') /1"'1-'11 ,,1t1 "llI-'r mJ.'.?"
MJ.'.1<\'f ?"C?"C 1''''I.(!l-tI .I:?" CflK,?" I'.I:?" 21 Blood and blood products used for the purpose
'/''I'}, M;>i'i'9" If~ " '<j>fll! 1''1111'0 '!':J>?" of saving life or scientific research may not
I''''I.YM''i uulf') I'M ') '?";: benefit both the donor and recipient financi all y.

1'.1 "'I')'i'(!l-1r' r 1.9"'1 r 1.?" 'I''/'}' /IN' flr.

fl.1'\'!' r"'l.i't'lCfl' f.U1~'"'' ,!"I--/, fl.l;>?'!' 31 Blood and blood products may only be given to
~Cfl':: a recipient after their safety and quality are
!III, ft111.lltI hlj:lI-'1''1 rUlIt.-tJ'I'<\'} A1<\'1 1:"/1 1'M tested,
uuClfP-''f 59, Organ and Ti>s uc Donation and Transplanta tion
Principles
/il f1.'IA )1fj:1\-1''J UlI{.-U'P<\'r 1:"1\ 'rM
"'Ih~-tD'} 1''''I.fl\(!l- 1"/'4'<]1(1 UJ.'.Cfl')· II Transplantation of organs or tissues may only
/I"'I.JIr')· CflJ.',7" I'(I(IJ<H' M-'} t'l"'liH"llhA
be carried out if there is no other better means
(\,II 1'1·7i1\ 1."'It·~
uu'}1Y: I''''IM'1 uul1''r
of preserving the life or physical integrity of the
Omh?"e; (ICY: (I,l;>?'!' ~(!l-::
recipient as proved by a medical board.
MI "'I')'i'(IJ<9" OUY,Cfl')·
(l(1)' t1UD~' Cfly.?"
Uy.Cfl'" 'l(l.(. 0".'1 I'n 1ttl lllj:lI-'1''J UlIl- 21 Any person may donate or prohibit the removal
U'P<'I')"} I\UDMft CflM" Or'}?" qf!.,~')' of his organs or lissues in any other way while
II''!.;/' ~,')-'lJ.'.Cfl(l1\. (luuhAhtl J.',';f'ltl:: alive or after his death.

L'I "'I'}'i'(IJ<?" (l(lJ< OUK.Cfl')· <'11\11- CflM" h'l"H"

R".'I 1'1.'ltl h'l:I\-'f1 CflJ.',?" UlIl-u'P<'Ii'·'f1
/I"l7it'l11- 'Ot'l- r1fl (IJ< '} :J>tI Il"'l'}~'(!l-?" 'l..lt
Illf1 /I.7ic J.',i,,,tI::
iii . f1.1ltl hlj:tI (1)Y.9" Ulll-u'P<'I'r /1;>0' Ilh~
A(I'O '1·'/<'In-r· 1'1<]CfJo'} :J>t., 011, U 1~'?' '}D·1l
n'}</'{) (i:) ".IPl. ')· f'lil. 'h'i.l'.If~ '/'t'l;Jo'
IlHlln(!l- "'01, ""IPd' 'If.l'/(!l- wm. 1I't'l'
11"/ /.').'tllt.t'l(!l- uum\'~' K::'j"'ItI::
31 A person may, at any time. revoke the act by
which he has promised to donate his organs or
tissues while alive or after his death.
n 41 Where a person who has promised to donate his
organs or tissues revokes his promise, pursuant
to sub-article (3) of this Article. in bad faith. the
recipient shall be enlitled to be indemnified for
the expenses which he has incu(\'ed due to such

-~-;
... ---
",-:, ~-- ..'~,: ~---
- - --
 -
federal Negarit Gazette No . 11 24th January,20 14 Page 7207

f;1 r"'l.h"·I1··}·1 rmt:NI" NMhII !!,If'OA:- 51 The following acts shall be prohibited:
V) f'>lliA n<j:l\oi'<; tHIl- U<P<\,l ' ')"11: a) trading in human organ or tissue;
""lj~i'f,Z' l

iI) filll A 11~1\·)'-'l U1Il-U'1'<\'}' nqnll7i1 b) receiving, giving or promising ·to give
fnll-fl9" If', nll'/1 ~n fAIf~ h,'}:f monetary or non-m onetary benefit for
on4'OA i ovilm1- CD.e.?" nqnilm'}- :1'1:1 organ or tissue donation;
on"l(t·}-!

til) fil'IA lI'}:n-)'-'O U-fll-U<P,'I-}-1 <j:"'H- c) advertising demand or supply of organ or

CD.f!.9° ~'-fC(l'l- "'1M-POI'} I tissues;

on) f7'}M')-1 I'hl]A 11'i:/'\-i-'i' u-fll-u<P<\')- d) using animal organ or tissue for the punpose
lin(/}- 1'1-11 '1-11''1 "'1'1'£\:: of transplanting it to human.

~.. U,eCD-I> I]IIL flO)- I'h ll.1\ tl'i":II·:r-'O u-fll-u<P<\-}-1 60. Organs and Tissues Collection from Deceased
ilfloofl-flfl-fl Person
fil h,}1: (\(J)- nU,eCD'}- n~nlo'l' CD'1-')' fh'IA II Where a person has consented to donate his
11<j:/,\-'I"}'O V-fll-U'i'<\'''1 nonf\1i1 h-/-il"'l"'l organs or tissues upon his death, the organs and
ffl(J)-fCD- u,eCD·I- il.fM: 1I'}q.n "-M tissues that can be used for transplantation may
1''''l_CD-l\- I'htlt\ h 'i:I\- :~,}'i' U-fll-U<P<\'P,} be collected upon his death,
oufl-fln-fl !!.r'\b\::
Ij'/ "'I'I~(!I-?" I'mS 'hl.'9u h'lnp'AIfJ'r Ar- 21 No health institution may collect organ, and
L:J>!: <\11''S 0It\! h 1-1'1\ '}O-il h '}ojo1\ (~) tissues pursuant to sub-article (I) of this Article
without obtaining special license from the
oo(\l'r I'hl]&I h<j:n-i-'I ~'O ulll u<Pil:'-1
Authority .
0011111\1\ M',:)'- A?"::
1IiJ>- nu,eCD'I- ~NI
31 Where there is no wrinen evidence showing
express prohibition of donation made by the
M<\ 1''''L.4'CD?''
~ ,}-'I~l1 l''''Lffl!!, 1'1\ 1I-<j: ODlJl IIA'I'71'l
deceased, while alive, and where the spouse,
children or parents or siblings of the deceased,
I'..,.:r- f-l--'!C 'l.l'.'i''i' M\i' OJj!,?" ~'l'r'i'
M'r CD!!,?" CD,}!:'1"i-'O ~u-r·i: h'}.l'.q..l'.9" in the order of their list, agree with the

'I'I1-1-'I1'(Il> OA'lilCD' h"-il"'Iao. ho:t:r- donation, organs and tissues that can be used for

Mht.'} n'IN, 'I'M !''''l.CD-l\- l'illJl:I transplantation may be collected from the
deceased.
h~n·:r-'O Ulll-u'I'fl'r'} aoflllflll ,l'.;f"A::

W OILU h1-1'1\ 10·il ,h'HlI' (e) CD-il'l' 41 Where the individual, listed under sub-article (3)
of this Article are suspected of crime for the
1"l-IlllI-:")- '1Mn'f' 1Io:t:(: '1".)- ?"In,l"}-
death of the deceased, they may not have th e
Oro,})(A I""mlm-:' hlf~ h..,,:r- Milt. 1 right to give consent with respect to donation of
t'nq.t'I ·,.M f"'l.CD-l\- f~,IJ&I h~/,\-):'O Ulll- organs and tissues of the deceased for
U'ffl1' Mil1 ou'}:;r.."; h,l'.)··I1-?":: transplantation.
(;1 1I.7i'i- n;r.fI -HIli !:1.7'lP'i·1 '/-h')'/'\- 51 Unless the donor ordered a particular recipient
h,)!: 1';1'(J}.p " '-I'I]~, rMftCD- ,rm.4''''l. as beneficiary in accordance with provisions of
h'M.If'} lJilllIt OilN'C I'h111o'\ 1I'I:fI-i''O
transplantation, selection of organs and tissues
UlIl-u<Pil'}' '''-I''1I':r- 1: &I.l'." I''''l.CDfI ~CD­
recipients shall be based on compelling medical
Othl1?"'i'CD- M7Jl~ Il''I.;1'P'): h1-lW-?"
reasons and the principles of justice and equity.
O~'rU'O C'}-(J ODclf>"i' 'If!. nononfll'l'
""If') ilIIO')-::

XI 1'11.70") u&I&.',- U.I',ro-}- r°'l.,I'l.7"1m·')- 61 Health professionals who declare the faCI of ·
fmS '111""'f>"1- hll-fl·)· J'''~fI' ""If') ~'i' death of the donor may not be less than two;
• '};r.n-'I'h'!CD-1 h"'l.flJ'l.-'!.'I- I'II\S (tn- and be different from , and have no monetary
relationship with, th ose who conduct the
f>,,:r- NIIIW f'l''1-?'' '1')1-~')' ft'lNfCD-
transplantation,
""If'} hf\ll'fCD'::
 -
Federal Negarit Gazette No, II 1.41/1 }wlUary. 20 14 Pa!;c n08
~=======================r====~ =
t./i. OUr.lDo}· .lJfl oor fhll" . h'/:{\:'1S'JJjJt:IJ'f.'I.: r1 61. Organs or Tiss ues Collection frolll Li \' ing
!'l.f\ooOl1l'lil Person _~

iii nUy.01'j-. Ilfl OlD' I'hllA ll'/:fl-:r·'l 'Hll- II Collection of organ or ti ss ue from a living
U'P<,\,j-.') unarM: f"'l.;fflar Ol'l?o. m.')~"l.<; person may be carried where competent
O,Ul

Uy.ID·)· 'If. PM.'; 11'11: hY.? I''''l y"Vl'C
uoll"r fI:I>-)' <JilTeD- I'm,'; IJl'lou' Y?>'!'
l'I.;1'oo·)fl')·" I''''l.h·/,I'I·')· 11-~.;1' p>~'. 1'1.":1,1'1'
f.1f"A:-
1/) fI.:>o. fl,),,,} 6,')' ~:fl- ". Yflar If,
(I"}')tj(l. 11,1:'. O'I'ooOl'I' 6.J'J: oofl"'l
health professionals believe removalQf organ or
tissue from the donor does not pose any serious
and pennanent danger to his health or life and
where:
a) the donor has capacity to give consent and
enter in to juridical acts, and agrees in

"'l'~') II-fl')' 9"flhC'1' IJfI'{I')' (Ill' II''/: writing. based on infonned consent, in the

'll.:>1m I he; presence of two witnesses; and

fI) fl?o·:- b) it is established by the National

(Ii) h'/'1' QV, ?C f')',I\C "}'r'i-~')' O1~9"
I' f! ? (]l f. 9" 1'.:> fI;f 119"J: e; J' fI eD-
oolf~'l 01,1:'.9"
(11) h'I'</'<J~ ?C \,')·.I\C "I'),hl' 11JJ!,9"
ffl? (]lUG I' .:>fI;f 119"J:<; 1'1I.1'IeD-
(l,If') {lII-I'\'/: oo'lhA 9"')9" ~~~'l'
1''1'0}>9'' "}'r'i·~'l' Moot;'.;. I
',-' ,
!IIlu J'.'HI h')-l'f, ;li~ (I'I'm</,oar l1t1"t·'f
!'hiIA ')o}>fI 'I'M /'I"'l.'" h.,·t:?7m::
V,I I'ILU h')-l'1I' ')o-f! h')-l'lI' (Ii) UA 'I'&- (II)
J';').:>1. n,<;'C9" flhllfl 0010') 'IAJ.lO (lar
nM.<!7.1D' 6.:I'J: rCf!A</: h'l")o)' Ufll U'I'f!i 21
oo(\{lflfl y,;flltl::
tl "'l')>;'O1·9" '1'*9" h<JflP'AtlJ~ A~
1'11\,';
6.:I'J: f'lJ'1~ flll,U h')<j>l\' ooM')" rhllA
h"~1I-1") he; Ufll U'Pf'l'j-.') OOflfl(lfl hr.'!' 2i
A9"::
Transplantation Committee referred to in
Article 62 of this Regulation that:
(I) there is spousal bondage or relation by
consanguinity or affinity between the
donor and the recipient; or
(2) in the absence of spousal bondage or
relation by consanguinity or affinity,
there is no monetary relationship
between the donor and the recipient.
Notwithstandi ng paragraph (aJ of sub-article (I)
of this Arti cle. bone marrow tissue may be
collected from a min or upon the consent of his
guardian.
No health institution Illay collect organs and
tissues pursuant . to this Article without

~11. M1o}>(l 1-M obtaining special license from the Authority:

iii "'l')'i'ID'9" I'm,'; '1'1:9" h<JflP'AtlJ~·

M
6.:1'1: f'lJ'1~ I'hllA h'i~fl-'!' he; Ullt: U'Pf'l,j-. 62. Transplantation .
1o}>fI 'I'M ,)'h9"<; h1A"}fl--r') ooflm-)' II No health institution may transplant organs and
~1f.~··A9":: tissues without obtaining special license from
MI IJflP'AtlJ~ I'hlJA h<j:fl- :r.') h<; uflt: the Authority.
U'Pf'l')'') oo(lllMI" ')o}>fI 'I'hll rhh9"'li
O'I'OOflh'I' "'" J''l! P'~ 9""}I)';' ') '/-h')'fl- 21 The Authority shall establish National
MODh~·(]l~· I' "'l.J' t: .:> "} 'I' 1l,h.t·'l! !'hIJA Transplantation Committee with a view to
')o}>fI ·/-M /1"'l.'L- n:<I<"'lA:: ensuring that organ or tissue collection and
transplantation is being carried out in
el 1lrh.&.'l! I'hllA io}>fl '/-hll /'I"'l.·~ar
accordance with professional ethics.
hJ">,I\'),I\. ') i")o}>fI 'I'M 'I' N' f'ln1::" 1"):"fI
31 Any transplantation may not be perfonned
'I'h'l rhh9"e; h1A"lfl-'j-. "'l'I'/,1: h~;fA9"::
unless the National Transplantation Committee
1f'~9" MI6.'I'/. I', (l, 1~ 'n,h.&·'l! I>"'/.'L·ar
approved the transplantation request; provided,
"hAA .\:,:)1 fI"'/. **9" I' hlJA 1:"fI 'I'h'l
however. that the National Committee may,
1>"'1. 'I; r P' t\'IJ') ol·IIt1" fI.(l'l' ~'f"tI: :
where necessary. give delegation of power to a
transplantation committee established at
regional level.
 -
7l\" :.1lMj'jJ t..s.t·A ~.'t·l· ."Ln, 'I'~'C Xli 'rc :;~ ~"l KiU ~ .?". Federal Ncg..tril Gazclh: No, 11 24'h Janu:lry, 201 4 Page 7209
---- .- ---~~
--~-~~iP'F PART SIX
MmS fjft-$'9':j~ HEALTH PROFESSIONALS

?"o&-'I: h1f: CHAPTER ONE

PROFESSIONAL LICENSING AND REGULATION
M-f M· l.:!,f: M"l'r'1 4J'l"rC
63. Designation of Health Profesliions and Requisite
gr, rillS -f?,'f1 M(TUM'iro '1 ll,~oo'f I-"t- in.: of Professional License
Ml."1.~r
II The Authority shall designate, register and
iiI 'lftIUAffJ~' fmS ~IIOf>.f?':r-'}
license he alth professionals and set Iheir scope
,l',OffJA! )"oull"lflel! V_.f I-"t-
of practice.
,l',O"lA! I' (1U. Y IV (" CD(I') R-CDfl'1 tI::
21 No health profess ional with professionallicc nse
Ij) 0n~'(I}9" I'{TO'Y 1-"('. /'.:n.: f'/'Om(/} {'m')
may provide health se rvi ces beyond the scope
'lftOO'f OAf. 1>111.'\1'0 (1.'1,;1' h"l'l11 YIICD'
of practice of his profession unless with special
Nitl O"'lJ\m(D' tlf. (/}IJ'L I]tlln OM'4'C
decision of the appropriate organ in exceptiona!
hoo.,!'(D· {,flt· (DO') (D."};'. "'l1'i'(D")?" 'H',~·)·
compelling circumstances.
I'm') h1A"IIt-')· oullm')' h,l'.)··tI?,,::
31 Any person qualified with more than one health
el hh')J:': O'l.l'. r(}'~ !'mS""'$' YoOl' !IO)'
profession shall be entitled to a professional'
M/,.'I1.CD·') oufl;'.C·)· MI]"J." f: I.fl I'm')
license to practice all of his health profess ions
fllll7D·f Olf~/Fr·(Il· au·;?,'·),· I)·ft· oo{]t··)·
so far as he satisfies the necessary requirements.
f"'l.Yfl :l'IICD' I' an·~' I-" t· l.:}> f: "'l"l7')'
j!.)~'ItI::

64. Health Professionals Register

g§. hl\m'j' Ijll-,I'?''f 01>11111
\I The Authority shall have a register for
iiI '1111-" Nll~' OId'I'II'Y CD·ll']' I-"t- I)j!.
registering every health professional practicing
1''''l.1'5 "'l1'i'CD''l?'' I'mS Ilo-f fl?"!
in Ethiopia comprising his name, nationality,
tt"l~')' oof.(l~' \'oo';'I.Y') I'rut- hf:Cr7i 'h'1
principal residence and place of business and
1\.1t-~'9D Mit.'\? onl.p.9''l~1 1''''l.WIt 0011111
such other necessary particulars.
,l'S/''PtI::
21 Any higher education institution shall send its
fl "'1'l'J'CD'?" I'h<j:·/,'i' ')'9"UC')' 'hl:?" OmS
graduate lists in health profession to the
00'.1' IIC'i: 0I'1.1I.(/} f"'l.YflooC:}>;I'CD·') 9"<;-
Authority and appropriate organ.
:1'1 11C11C t'IIJoruA"l'r 'h'1 h"lll11 'Io(/}
hl]A 00'1)) MO')'::
31 The register to be kept in accordance with sub-
;:1 OIlU h')4'?;, '10·11 h14'l\' (Ii) ooll/.')· 1''''l.Y1I
article (I) of this Article shall be open 10 the
00'11111 ),1Y.M6JI1.'I·I, o;hll'O "IA'f. (TOY.I."1
public as may be necessary.
MO')'::
65. Issuance of Professional License
~l; . .I'oo-f flt- l.:I'f: Moullmr

/il "'11'i'ar?" I'mS IlIl00-f Ililrutl"l~' om') II Any health professional shall be granted with

oo·f fit· l.:I'f: YOJffJ'foJ-') oofl/,.Cf·';f· health professional license upon fulfilling the

h":l. A f. 0. 1'I I'm') 00' ,!' rut- l. :I' f: requiremenls set by the Authority for hea lth

,l'.Om'PA :: profess ionals.

'1.1 h"lIl·O YIlrJ)' hl]tI hilA II1mooar I'mS 21 The appropriate organ may issue restricted

1l0{TO'f 'h1Y. h"lIl11H 1Y.11 \,·J-.r.1.10·)· I'mS professional license, as may be appropriate, for
oo·f rut· ;'.:}>I!: oJI'r ,!':')"'ItI:: impaired health professional.

;:1 '"11"'(0'9" rIlL <; 'lOuo· .I' O"'l'g'(Ir?" (TOAI!' 31 . No health pro ressional may in any manner

roo·f III.· /,.:1';;") 111\.1) (IIJ./.", CD?') transfer or rent his professional license to lhird
t'l.YII·/''ItI<j: CD)', ?" o.fht·)', h)',~~Mo:: party.
 Federal Negarit tiazcltc No. II 24'ft January,2014 Page '/110

81. r - r flt· t.;Nf: M"'If\UI 66. Renowal of ProfessionAl Lieense

(il OI,'P»; h'Hr, l!it(~) (]Vrll:')' O~'l'i'or9" VmS II In applying for renewal of professional license
flt'lno·J' l'un.J' I»t- '.:/,~') t'l"'lllf.it in accordance with Article 33(2) of the
I'I.·/'Cil:· Proclamation any health professional shall
present:

II) 000'.1' IlC1· '~Il;J';J-~ v=-y "'11AM' a) certificate of completion of the required
(]VID·M.·) YD 'l.J'l.'1"I'l' r9"ithC ID/''''')'I continuing professional development in his
).<; profession; and
t'l) (]V·J'ID··) 1'I"'lh<;ID') V"'1.Yit'l'A VmS b) medical certificate proving his fitness to
II' 'b;J- ). ').I" t'l or 'to'Z,J't. .'1"I'P V.nh9"<; practice the profession.
9"ithC m/.,H· 1
"'11'/.·0 ,eSCO;J'A::
21 For the purpose of this Article "continuing
!l.1 I'ItLV h1.pl\· ll'1A "'~h;J-;J-~ 't-Y "'11t1
professional development" mean$ a training
0;1:" "'1(\.). '1fl1»A"l~'
O"'1.Ym"lor (]VootY
periodically anended by a health profe~sional
ooM.·)· "'11'i'or9" VmS 'IlIu!).! 0P't- II)?,
during his practice to maintain his professional
M'II non'J'or Y1'ior') ).or.p·)·<; hvlt-·)· knowledge and skills and enhance his
m·tH'- I\·i,e",~,e. 1,'1 \'Uo.J' '0:'''1:') t'l"'l~AO')' professional competence in accordance with
nY·W.m· 't"'1.lD!lf.lD· P'Am'l ~or:: the directive to be issued by the Authority.
~. !"Hlm r - ! itt- "N: r"'1g.itt-ot '1~ 67. Inactive Slatus
iii "'IWlD'9" rmS flt'loo·J' hl/·t'l·)· '100')' 0I1.e II Any health professional who did not practice
O"'1')'i'or9" 9"h')f·)· n-!or II~(\(" hollr his profession for more than two years for any
IDf.QU·! P'':·ID· hooooM· n.,·)· h"l'l11 IIt'lor reason shall notify the appropriate organ prior
hlltl "'111ID:r MM·: : to resumption of practicing his profession.
iiI h'7'1'O ,l't'ltJI- nllA OIl.V h1.pll' 10·11 h'''''lI' 21 The appropriate organ may authorize the
(Ii) r·~oot'lIl·"'J}o '1t'loo-Y ~,1f. h"l'l11'I'~ professional referred to in sub·article (1) of this
'I'h;J-;J-~ 't"".y "'11AOf oom·fl.'\.·) Article to practice his profession upon requiring
'1 "'1.n .'1 "I 'l' "'1 itt. :<I ). ·i·'tt 1'C 11 ; II '" m<; him to produce evidence of completion of
).'i"l.(JJII.I': ro$W' nllA flt'lP'A"l~' nO'Z,uoc continuing professional development or causing
mor 't mS 'hf;9" or II'I' nO'Z, 1~ 't mS him to anend training, or to work under the
flt'luo.J' P'C Mlllit~ 1,tL nh')--)'A ).1-'1,(\(,. snpervision of a competent hcalth professional
O"'1.1':t."1 O=-Yor )'·M.itt· 1'I. ..:r.l':t'l.). working in a health institution chosen by the
~~"IIt1:: Authority.
i.'1 '111<70' y(O. h 1i·1I-)· 'I""')' Oll~ 000.Y(II- 31 If a health professional who did not practice his
1I~1'I6· .~ Y,'y, n'7'1'O 1111(11- hIlA IIyllar'l- profession for more than two years engages in
practicing without notifying the appropriate
.I': .'1°'1. Ou!). YID' 1'I.1'It- n.1~ Ylloo·Y itt- organ, he shall be deemed as practicing without
":/'.I': h ·if.... ,:· .e·f.m':·A:: professional license.
8;;;. nor'l" h1C 'tMm~ rmS flIIOD-! 68. Health Professional Trained in Foreign Country
iiI mil .I':i11 h·).pll' ;';'?i(?i) .1':').'11 ).').I'.·I-m01' 11 Without prejudice to the provisions of Article
lf~' ).ID·~·<; 11 ... 01' rm·"!."
h1C '1'*9· itAm<; 65( 1) of this Regulation, any person with a duly
recognized foreign educational background
(OM'. II"'" Y 9"111'1'1 '.:/'f.' 'l' Yot 1'0000Y."C11
applying for professional license shall:
"'01':,
a) produce evidence of equivalence of
tI) I»Ann '111m- "IIA 1"~1I1Il 1")'9"VC')' qualification issued by the competent body;
"'111t. Jl h f "19"')' "'1/' .'1?""L "'1;p l. 11
MO')'! b) complete from six months to a yearlong
II) 0"'1·i'1m·9· m·"};" h1C O""'Y(II- t'looll':··)· intemship program at assigned health
'.:/'.I': ',m"l'-f' hll·lI-)· 'l""')' OilY. institution by the appropriate organ where
YAII6· hlf~ h"l'l'O YIIID' hll'" he did n<?t practice his profession in any
O''1.uu.l':nm- fillS ''''119'' 1111.1':11')' IDC foreign country for more than two years.
Mh h·).e: '\UD')' f"'1..y.y, \'''-·i·I·C')o.T
T (:' "It· 9" "'I fIl <; 4':to ~ '0' C 0;1' '" ::

. ~ ...,... ... ~ ""'~ .

.. ~ .. - .-..
 -
Federal NcgaritGazettt No:'1 24lb January. 20 14 Page 72lJ
~~~~~~~~~~~~~=========== =
I]) I'II.U 1,1'~)1; ·}D·h 1,"'/')\' (Ii) J:1:n fiSC?" 21 Notwithstanding the provisions of sub-artic le
hll·/I·)· <}oo')' O'lY. (lCO·"!." h1C Y1I11/1 I'mS (I) of this Article, a health professional with
fl/lOD'J' 1'·""'Il.fl')· coy.?" I'M·fl·)· h'IC more th"n two years of professional practice in
I'flo;.!· p'C"l."·)· hlt,')'l'k,l' fflO;.l' P'C"l."·)- any foreign country shall complete internship
.?C 1''''1.e''l''l?'' hln 'l1\P'A"I~ fl"'1.coll)ro' program as detennined by the Auth ority if the
f'flJttL')' \'n.~H ·C·i?i.T TC"lt.?'U U'fmc;'I'~' di sease pattem o f the country of his trainin g or
j?<;'CO;.l'A:: Practice is incompatible with Ethiopia's di sease
pattern.
1:1 1'1I.1I h14>)\' '10·11 h1,~)1; (ii) h<; (lI) 31 Notwithstanding the provisions of sub-article
t:·'.n?':-': fi.':'<,?" <I11P'N']'" hco-"l." h1C (I) and (2) of thi s Artic'e, the Authority may
IIh"l."C 7.tt fl"'1.·P.\'. I'hClI;.I' Ilt· i 11M• .? 7.t1. issue temporary professional license for a health
1'(\11<}'l? hell;/, coy,?" (iflIlI"A"I'" fl"'1.cofl'" professional with foreign educational
lIt..tr:f. I'mS 1,1A"III'.r,:I: 11"'1.0011\' background , where the professional intends to
provide health services in short tenn charitable
CJlloo-J'?':f 7.llJ''l? 't_.r Ilt- /..:I't: II.fl'l' activity, emergency humanitarian crisis or other
j?'f·I\A:: health services to be determined by the
Authority.
iii fillS Q/lun',I'co"} O?lt,l''f'n· ,l'lloo"lco' 41 The institution which brought the health
1'*?,,:- professional on temporary basis shall:

II) CJlloo· YeD- .~ MI'eD-" II.J'Ill<;H' (1)1\. a) upon the completion of the professional's
J'CO'''' 1IIJ1lp'A"I'" 1''''11'\co:P<; /..:I'P,. mission, notify the Authority and ensure
h1·.tooflll "'1J:/."I MO'}'! the surrender of the temporary professional
license;
II) fllloo·Yco- o"'1. I'l III CO· fillS h1A"Itr~·
b) bear civil responsibility for any damages
1I"'I.J'.C{t 7-1I~' r"'~'hh l1,h.C ::>'l&,)')- caused by the health service provided by
.e<:'Cfi;/,A:: the professional.

~I!. f - f P't- .!..4'1.'1 !lIIooooll!l 69. Surrender of Professional License

"'11'i'co-?" fm.<; '111-Y f'~flmco- I'-Y itt- Any health professional shall have the obligation to
/...4'1: (t;.l'1 J: CO j?9" (t fl /. 71 CO j??" I' OO"lfl'}'1
slU'Iender his professional license where his license
,,.,M/1 (tlm'l:":P COM" f - f flt-CO-'t fl,'I'm-
is suspended or revoked or he completes his mission
f' 00- lilt- /..:1' J\. 'I IIIJIl P' A "1'" f' 00 00 M "I ~ ;/'
M n-)':: or relinquishes practicing his profession.
9" 6t-'I: trfl-r CHAPTER TWO
f'm", flfl- f I"~ 9"'?flC HEALTH PROFESSIONAL CODE OF CONDUCT
it, hm.t"& ODC IfE:f 70. General Principles
"'11'i'co-9" I'm. <; 'lll -,1':- Any health professional:
lit M':<t'l! j?U') .l'.'Hl roj?9" h"l'lll ,l'lIar1 II may not practice his profession in any manner
"'1"'i'CO-'I9" U"/ 0"'1.'1'11 ooAh· P't-CO-1 that violate the Proclamation, this Regulation or
"'1h<;C01 fIlO')'9" ! any other relevant law;
~I J'It?"1?" hJ: A?'
I'm. <; 21 shall provide health services to the client
111'1A.?.e oollm')' MO')' l without any discrimination;
[I 1I-I'1A.?).'. m.1)·)·<; '1:1\'/')' :PJ:"'I.f oollm'}-
3/ shall give the utmost consideration for the health
hlln~'::
and need of the client.
itIi . I'm. <; - f P'~ 9""I'l C /1"'1.1:
iii f'm.<; oo.y P') 9""ICJC 1I"'1.,t (hllU OJ.I\ 71. Health Proressional Ethics Committee
"/1"'1."''' hl'-rCJ1I l''''I.mt-) OIlU J'.111 1/ A Health Professional Ethics Committee
"'*4<",-A:: (hereinafter the "Committee") is hereby
established.
1/ 1't>"'1, ' ~CD- M"~' 1,"Ifl11H' tjl\'fco· 1''I:'''1T
I' "'co'''Im' CJlloo·Y9'1'· tnco- 0"'1. '1. 11 T';' 21 Members of the Committee shall be
.eM"'1I1· j 4<'I'&· 'fco'?" h1J'.Mt.tt7. H, j?CO professionals drawn from the relevant
fI'lA:: institutions and be designated by the Minister,
and their number shall be determined as
necessary.
 -re-'=-- ..= = ---,=_. ====~"'i""~~~===-=-""""""""'""""""--
Fedcnd Neg&rit Gazer..c No. 11 24'" January,2014 Page 7212
-
!fr. 1'/1~:!:(]l. ~t1~5. ~1!,.jiJj:. 72. Powers and Duties orth. Committee

/1"'/. ·W}:· The Committee:

iii .l'.lJlar') fjAmn.p I'mS h7A'7(1o·)· ).·)~tr9" 11 shall examine, investigate and propose
flj-·)·<;, oo',f"e 1"'~·9"'7I]C O1.1'.lIar I'mS appropriate administrative measure to the
1]11- f 'If, rD'l, .pcn- il't.;J- JD"!',} 1-.pfl(lo
Authority on complaints made with respect to
J'''1t·t\ I f,ool9"lrtl ilOlll.l'.' 1III"'/.71]ar
substandard health services and incompetent
hfH·P,Y.Ir'e ).C9"Ji rarl'l'l. '11'1 '0 Mill'"
and unethical health professionals;
A"1~' f '~C'lA!

Jl.1 !'4>lnll')"} nil 11"'11':" 1''''1.0:1' "'IlllJi 21 shall, where il proves availability of sufficient
00'1';") ilJ'l.?'7'J' I'mS fill-far 0lj?9" evidence to support the complaint, send
'r!!:"'" ""tll'l") Ml .p'} arll'l' ).'}~f4>CfI summon to the health professional or institution
Oou'J'6J'ar 'If, 000'71111' il't.;:I-(1l. lI."lno·} against whom a complaint is lodged with the
hIlA f,Nltll notification to respond within 30 days;

l'1 ?'I'lflOl'/ ;P,;,;t- ).'})'.Mt.'I1. ~,,,

1I°7"1Ir')' 31 may, where appropriate, assign an independent
M.~I"'.VT1~· .?C non"'lhC 711&11->;' 0"16 researcher in consultation with the Authority to
~\'It\ 7')·V,.ffl](,·tI,)· tI.II)'.!!" f,':j''IA I investigate the complaint;

iii ~'7 flar (J)o''1'1. hIl h"'/. 0 'I' Y: III I' - f Illr 41 may propose suspension of license or certificate
t.n: mj.',9" I'·o:l"}· "'Il.?7""1. ?UlIhC of competence to the Authority until the
Oll</>')' ).'}~;J-1Y: I'arl'l'l. '11'1-fl MIII"'A"1~ appropriate decision is passed on the complaint;
1lJ'4>C·jJ )'.'f'ltll

(;f Il1- y..? .? "'/. I' "'/. ."cn- iI' to;J- JD 'f '}<;' M .oj, ;J- 51 shall, upon identifying the root causes of
JD~"i up'IIl'l.JD'f 0"'1'1'<;")' ,'"le''ll ml'l<f:~')' frequently lodged complaints and grievances,
M"'I.•• ·pn')· I}·'I.;!· I'TII.i'l. '11'1n:h foo~ propose policy directions intended to provide
sustainable solutions to the problems;

:;; II.II-'f Ol]tll"'':V'1~ 1''''I.om')·'} ''''7'lIr')' 61 shall perform such other duties that may be
fh<;,ar<;'A:: assigned to it by the Authority.

itr. 1'1l'7'1:tar lIf1MEX 73. Meetings of the Committee

{ill> "'/. 1;ar III'"/.. ar 'litt.1I1 aum'} f,on M A :: II The Committee shall meet as frequently as its
functions requires.
MI 1I1>"'I.1:(D· M'.-l· h"l"'li'i O'lf, r"'l.If'rr 21 The presence of more than half of the members
01>"'/.1:cv- Ilflll'l ttf, 111-71' 9"A't1- 7·'l'l. at any meeting of the Commi"ee shall
)'.1f<;'tI :: constitute a quorum.
rl I'I>"'/.'~Ol· 0l·I'I'I. 0.1'.'9"1.' flA65j, .I'M·A! 31 Decisions of the Committee shall be passed by
1f,9" .1'.'9"1.' ).h·A O)'I1'A h~·ht.t1 itfll'lflCII- majority votes; in case of a tie, the Chairperson
I''''/.Y. '7 t.m· 0l·I'I'I. ,r tI 'i·A: : shall have a casting vote.
v.1 I'llo iI'}'l'lI' Y:V?JD'f ),,}y.1-m041 If, 41 Without prejudice to the provisions of this
/1"'/. tOl' I' Iro''} 1'1If1o'l I"'~ I"'C'tr Y. '}fI Article, the Committee may adopt its own rules
ilfOl"1 )'.1··'ItI:: of procedure.
itli. !'m,','ll\oo'}' .'!''i''E'i. '11,i-HJ· 74. Main Responsibilities of Health Professionals
Any health professional shall:
II be accountable for the health services he
iiI ). ,}1.llt· .I'.·C7iOl· o"'/.omar I'mS h7&1"ltl-,).<;,
provides and for his decisions as per his
O"'l.Olll~ar Cll-I'I'I. ''''JlJ'oj:~'). MO')" assigned duty;
if 0 "/l]fI I]tlCII- 0'7 oulll'l' I'mS 07&1'71'1")' 21 obtain informed consent from a patient, in
lloullm1: 06.')' l'·r7&1.:>f.') -it· {,.j-.I'.' accordance with the relevant law, before
D~''I1-)' MO-)' I rendering a service;
 •

1)1; liUE;: t..f.<'rA l.ot·)· .:>'1"1 ·',1'C 1:6 'rc IX i") ~lI.l ~.9". Federal NegaritGi!2C!te No. 11 24· Jan uar)",20J4 Page 7213
--=-==~-=-==-=
-=
CI hao'J'
- ==-
==-=========r========='----- -'
>,;J<-9" In h"'1t1)j?, ,;>C 31 provide genuine and adequate information
--
0"'1.,PJ'.C10l· uo.,p'I! "J·n·J·)· hlD'J"':;''1 01: during profess ional communication with
oull'l oulllll')' Mil"'1 colleagues and clients;

§I 1"'-1t1,;>\'·,} "'I,1l,),C ' l'''ItI mj?,w'}" 9"C""l'1 41 respect patient confidentiality. privacy. choices
h-l1C oumn~' non:/" and dignity;

til WI-f: auN,Y" /"~ '""I'lC'> 11-116'> I'IS l.W· 5/ maint3in th e highest standards of personai
j?,11JtI j conduct and integrity;

'!,I ilo-,f:'} 11t- ro-l1,), rMm·'} 'If\au-y hilT'!'? 61 discharge his professional duty in a team work
O"'1hOC 1''''1.mfl')'O·)-') au- Y'e '/ 'It. '/,} respecting the contribution of other health
auOlfIJ-l- MO')" professional ;

1.1 '1'10,aJ-'} l'9"hC 71 provide appropriate counselling service to the

aullm')' MO')- i client;

'/;1 OI"I.lblD' O"'l,rom· ~,!lJlII I' ,),h9"'1 '~h<;' h- 81 update his professional knowledge and skills to
Jl.p'i· h'1 "I'H'l' un,y'!! l,w'>/>-j,'),> hllf\u'~,) new medical technologies and innovations;
"'1 M .. "I j.'. <;' CO;/' til

YI h;/,'I"'I,ro·'1 hf\.f\-:t I'mS Cjf\au'YP'l ,;>C 9/ maintain proper and effective communication
~ "Ilwer, <;:/",P"'I "IT'I· ~,). 1'1. <;' lro· j?,1IJtI! with his patients and other health professionals;

II 1';/'11"'1.0l·'} ,H,M>;' ra,h9"'1 (1001 <101f"J(l 101 register and keep accurate client records;
"'1M'au')' Mil')"!

Ilil O·!-uoJ'.OO·)· (l;l"r, 1'1lt· IIq,)· Ollt· 10;/'ro- 111 avail himself and provide professional service
'III, iluo11-l- "" .. y'!! ~1A"JI'I- ')" oullm ')' in his working place during assigned duty
MO')'j hours;

Ifl I'l)fll,NI-I1 mS TC'"Jt-'l"~"} O"'l,>/>Cl\,n-}-'1 12/ ensure public participation and acceptance in
0"'1,'1'1-0CO')' 7,tj, 1'1)'01.'1·1\0· '} .I'.... ;/' ~ ../7·'i designing and implementing public health
t.:j>f, "M- "'1l,;>7')' MO'}-, programs;

If:! au·yOl·'} O"'l,<1Ol'Ih')' '/'P,y, 1,'7'l'fI J'f\Ill' 1,11/:1 13/ comply with any lawful instructions and
1''''1.tlmlll·'} U;J'P. ')'0'111'; 1''''1,,!'mfIJro·'} procedures of the appropriate organ with
I'hlP/'·C I"Cq,} ",/),oe MIO')':: respect to his profession.

~~. l!O b7A7o-t h'Ef'1 /1"'1, 7i1 75. Fees and Commission

Any health professional may not:

fil f\"'I,lImro- h'ltI "11'1-'''' h"'1.mj.'.>/>w· 1'~1t1"1 il accept commission or any benefit apart from
fl-'} h<;:,i' .ro·m, h"'l');;'cD'9" IIcD' cD)?9"
service charge from a person or another healih
fillS fll\ltu-..f' mJJ.?" -I':J:9" tltfll.7i'} my.?"
professional or institution in return for the
0'l~' 'I'a)o'}?O ')'~,?O (I"ml")' OJy,," f1o'~ntl

I'fIn:"?" I services he renders;

MI 't1A;Jj?, h')Jl"ht'l'-" lI.tI 1'I"'11'i'ro'9" flw· 21 pay commission or offer benefits to any person
tt"'l,7i'} uol/t.tI cDy,9" o'J'1'1'al-'}9" 'ro/? for recommending patients~
<1OlIm')' l'fIn')"," I

!.'I DO·Yro· 11"'1,6,')'.<'.(0' ro'G1J, h1JlYh'>ro·') 3/ offer or accept any payment or benefit which is
(O~9D t1"·.f'm- \JO'l,mf,·f>(D·'} ), 1~J'h{";m'1 intended to induce to act or not to act in a
'1'0<;' fl"'lI'lY.C m.e?" ;I"I"'I,cD' t1 u hU\
particular way not professionally indicated or to
11"'1, ?lJro· Oil,!'. h<;:.I' h ·)-'\,t!<;:tI n"'l Yo'l "I
over-charge patients;
9"19" qj?,"T h .. .I' roM" M 'I'~,9"
uollm')'9" If~ f1O'~nA rflo,}'9":
 -
Fcd\!r.l1 NegantGazctlc No. 11 24th Jm~u:lr)', 201 4 Pllge 72 14

iii 11(.·1\· m,!',9" MII1L!O' mJ',9" r.flC'·)· 4/ charge or receive fees for services not rendered
O"'l.l\t·(o· mg.?" O?"·)·!iH· fluu.l'.oen· ~lIun',r
personally or by his em ployee or pallner or
1\<1'010 rill S r.'1.\,'M..)· IIAIY~ OIl'f"~C tJ<i:.l'
substiiute;
"'IlIht.A m,e,?" an</-IlA 1'1'10-)'9" I

(;1 'I'-'A_~ g:) t'\,MI9"<; m.e9" l'I;htJ9"<; uo·ht- 51 receive payment or allY bellefll for
en,!'.9" I19"C9"C en!'. 11.1\ mS · ~1Iup-J' recommending or referring patients to another
tl"'i!l'f·IIM· IIILU' r.'IA "111,,,1, htj:J' "'IllhU\ health professional, for treatment or· for
m,!'.9" 11.1\ 'N'?" u.'I'IlA \'1111')' 9"; participation in clinical trial s or other research;

%1 Np.)'9" O.A r ;).11"'1.(0·,) f mS 'f"1C 61 provide health service, for his benefit, thai docs
{,"'I,!'.!..;J' fmS r.7A"1I1·')· uollm-)' nol serve the needs of his palien!.
\' oM·?"::
it~, hM . l'mS ~11"",r ;>C . MiTDFt-.T 76. Practicing with other Health Pro["ssionals
iii "'I')>;'m'9" I'm.<; ~lIuo',f 11.1\ I'mS '1l'1uo.y
II A health profess ional shall employ a health
"''1'c.' "'1M·} -i'4'fTlten· I'm.'i
\''''1. :r-O(D'
professional who is licensed by the appropriate
tll\ou·.fm· 1."J'Hl qllm· hilA 1..,1-)'.' 1'+l\mcu'
organ.
hU", 'an·::
21 Unless for training purposes, a health
~I 1I')'Y"IlC'j-<,' rAm'; IIAln IIIH'4'C 1.,).1'.'
profess ional may not work with or give any
\'m.<; qlluo ..f no/q·n '111m· hilA foo.y 1. .•4'.1'.'
kind of professional support to another health
lIA'I'/I,,1I(I)' 1\." \'mS ~lIuo'J' ;>C iJ·OC
oull(.··)· m,e?" 1'111.0' ~lIoo',f "'I'l'1'ro''l9" profess ional not li censed by the appropriate
''I,!'.)')' uD·,f'r. .r:;>,/: 00 11111-)' 1'1'111-)'9":: organ.

l::t. 1'_ r "'l.ll '1'C .1lfIoomil;P 77. Profession.1 Confidentiality

(il 1,"1'1 ·0 '111111' I,IIA 1l1i·0/.·I'I'0' mS 7-:<l.)''' . II A health professional may not disclose, verbally
f;J'ou',Il')' .] . .<;,1'., IIAIJ') , IIG~C)'.· (1,-). or in writing, information regarding a patient
IIA;J'IIII' I';H I"'1. (D.') 119"9"',.)· 1111']1 m,!'.9" unl ess the appropriate organ believed that there
is a prominent health risk 10 Ihe public
Illl"} P·I·!.."'.\?' llAtn III1-HoC "'I'}>;'oH"
demanding to do so, it is ordered by a court, he
Ym."i qnao.Jl ;.H,U'l.(I}·' ~J(1'l.t1Dt\h+ o1rF;:
gets writte n consent from the patient or the
(Il'-)?" oaLil 1I.'JoA mg,9" Illl·,h·<i: oD"1I1'}O
patient's guardian or it is permitted by law .
mg,?" ooilm')' l,g;:i'A9"::
21 A health professiona' may release or transfer
~I UtJ·F;-:cu·Y P
\'mS . ~lIuv·.l' ;HI"'l.P'i·'} information regarding palients for the purpose
P°'l.unMr uo/.Wl M,e')<'I'!? ?"C9n C roM" of conducting scientific research or studies
'1'<;')' '111°7 uo"/I\'I' CU,e9" "'111','1\11 <i: where the information released is in such a
\""1. :r·1I (IJ. f"'J')';'avW" ;.1-11"'1. "'I')~'r manner that it does not identify directly or
11<1''1' ;)·9" In fH '11'1"1' /. op')"}!'.· O"'l.l'flen·;P indirectly any individual palient.
1J-'/,;J' unIY') 1,III1'h: 31 A health professional shall encourage a patient
U 'T)>;'m'9" PmS '11'10.'.1' "'''"1., 071;1' .fl'lll+ with communicable diseases to disclose his
status to individuals with potential exposure to
;1.11"'1:) lluUOD.·) <'LYil·'·IIA~:'l'f(O·
the infection.
I'I"'Li'N':(Jl' (W'i~ ),'}.II.,rf\(O")o O?IIL;r;J")'
r.1'I1l·)-: :
78. Preferential Treatment and Referral of Clients
l't, f01A"IO=-t 00t:AfD5 ;rt)"'I.fDfJ Mool)h
II Any health professional shall render the same
iii 01'1",'(0·9" VmS ',I\£/U'P llooJl.II>;'<; II-)'Ctj: level of care to his clients in ilinerant and
'Lib lit· tl'/'7A;>g, 1''''l.l'Im/D· tJ·fl111l. ,,'00<'1 resident practice.
<'I.e, <lDlf'l 1>1'111')-::
21 Any heallh profess ional may not provide any
el "'I')>;'m'9" \'m.<; ,!I'IUD·.r 111.·l.\': fl"'I.!It·Il·)· preferential treatment to a client by considering
fmS 1',1;9" \"""""'l'" '7')1·',,)'-) 9 lJ'>Y+ u
the relations hip established with him in another
fl"'l!I:l'7 01'1.11 "'1:9" l\;rlIO>I.m· 111'1.1'1·:)'- health inslitution where the same professional
I>llllAth ('OD',r r.·IA"II'I")' u"l1m.)· 1'1'I11}9":: works.

-----""'.= _. ._.._.-
 .
Federal NcgarilGaz¢ttc No. 11 24111 January, 20 14 Page 72 15

i.'1 h1t1"II'I"'r. (lmS " ';:(lD' r"'1K;I"i Mlltllf'6 31 A health professional may not refer a patient to
J'II(IJ-') 1''I'~'9'''' I' I~' t- "I') "i.~.). "I t:I'/; another health institution where he work s unless
hj!:C7- 1'1 ,1- 1I"'I.W· MlJf:\1f\)\ ~:/.{I "'1'):;'(1)09" for services unavailable and necess itadng
I'mS 'MODo.!' hh').t': I'mS . ,.~?" W.~ (VI referral upon declaring the vested inkrest of the
1""I.I'II.·n·). rmS 1'~?" ;NI"'I.aJ·') om'lh professional in the referred health institut ion.
u
h,e.'··t:l9 "

iii flit u h ')",'/; ')0·11 ~, ')1''/; (Ii) ht.l\l\?" 41 For the purpose of sub-article (1) of this Article,
"oo.f.O>;' lit-" 0'il\,). I'm,,> 'll'l-J'W' M:"'I.~+ " resident practice" means a practice which a
-t-.,.'I'C' 1''''I.r'imw· I'mS h1t:1 "11\0> •.,.. fLlf') I health professional conducts on full time basis
"I'+C~ 1.tt. lit-" "'11'1:,. Yo "1'1" 'lI'lOO-J'(I)o regularly while "itinerant practice" means a
1100Y.n'i' lit- aJ·c.n, 1''''I.r'im(l)o I'm,~' practice which a health professional conducts
h1t1"1I'1'~' ~aJ·::. other than the resident practice.
79. Prohibition of Secret Remedies
(til. "'1.11 'I' t- 'e '" n?"" M (lDht\ 11'"
1/ No health professional may use secret remedies.
'{if "'I')';'m·?" I' .l,h?"" 'l1\t70. J' "'1.11'1' I.. 'P.
u 21 Every health professional shall, in the conduct
"'119 " 1'l.1'I'1' hf!,lM": :
of his practice, use only an apparatus or health
Mf "'I')'i' (I)o?" !'mS fll'lno'J' I'mS h'ltI "11'1-•.,.. technology or intervention whiCh is proved
o "'I.fl 'I' 0 ~. 1.lb 1' 0 1:IMt:lO')' 00o')6J' I upon investigation to be capable of fulfilling the
·~hc:'t'l·;{ aJ,e.9° ;/'h9"" ou'i:+'L I'l.fl'l' claims made in regard to it
" ')Yo "'1.1' t:I
oolf') Mn')-::
WI'' ' ' ' ' n?"c?"c r-t-l,.?1m
31 For the purpose of this Article "secret remedy"
means a medication or treatment that cures a
1:1 (lItU h'H',/;
ht.l\l\9" ""'I.il'l't-'f un?""" disease or disorder or relieves its symptoms that
"'I1I:r- U'~ 1"111\- 1\1\1\0>0)'. fl$1'l !''''I.Yon;r" is known by only a few people or professionals
0'1'-1:''''' 1'1$1'1' aJ,e.?" flllt7D-J' $1'0)'. ·M: and intentionally withheld from general
1''''I.;/'aJ;r 0 'Ii;/' ') 1'1 "'1m aJ ,e.?" r mS "f "I C,) knowledge.
t'luo-l-l'i: (JJJ',?" Uoo?",) 1'1"'111;/'111 l''''I.aJ-tI
ooj!:;)'l.+ aJJ',?" "'h?"" ~(JJ.::

it, ~-A'L~1J!)'ld~1 ..0(1"'1.0t.'l'$J),f. 80. Advertisement of Profession and Service

II Any health professional may not advertise:

()) h1t1 "11'1-.",) 1''''1.001'111''''' no·J''P. J' tlU'~ i a) his services if the advertisement IS
unprofessional, untruthful or misleading;
'1fl-t-:;' wf!,?" Mo') 1: fin l''''IIl''-'I'(Il''''
-t-"IflC 00t.l\9u f'lIn'''''9" j

1'1) h"l'l'O 'III(Il' 1'00 ')"11-"''''' hlltl t.1l'Yo' b) his services unless otherwise he is
lltl·t-flmaJ· nil-t- ,~C 1''''I.flffi(l)o') authorized by the appropriate government
MtI"III-''''' "'IM"P(ll~' h.!',:):t\9" j organ;

,II) \'00'.1' 1,'lt:I'1fl" ',') fLJ'Il " ·'I'w·~' .c) in a manner that directly or indirectly
o""r1'?" Il'~ n','II'P'I' 6 Milt.ll'L I'U'~ encourages the unnecessary use of health
f-t-1 t:I,.? f!,') "-~o') 7i~~' o"'l.t. 'l'C /I. '!.;:I' services;
0011'') I't'ln')' 9" i

00) Mt:I "It'd,') fl ..!'Il·'·'Pw"'" t'l.I'I'':{' f'mS d) his services in a manner that affects or
'It'loo'Y9'i:') 0"'1.7--'1 wY.?" 1,1t:1'?(t';J'~: undermines the services of other health
. (Il.') 1I:j> O"'l.,!'YOC"l (}' 'I.;J' 0011") professionals;
I't'ln:"9 u j

•
"') 1''''I..!'YoC1W· 1'00·J' "'Iil-I' 'I'w~' ·t-"I'lC e) his services by drawing anention 10 his
nt-fl· l'-t-7it'l f'uo'J' '0:/,70<; I'bw·",~· personal qua lities and superior knowledge;
I'n<'lf!,'".,.. <'Ix. f:II'. ·""h·':·). r"'l.J'fl'l'
0011") I't'lO+?" 1
 Federal Ncgaril Gaz.cUC No. II 24 1" Jauuary,20l<l Pa~c 7216

Ii 1\"'!.II m(I). A7A'?Il"'''' r"'Lyy.r.7(o· f) his services in a manner that promises a

t.)
\''''I{j'J'1' (I)~' .J'''I'1r. 1l·!·1A;>f. {jm;}'! gift, discount or other inducement to attract
r 7' ;> ~,',-Ii (OY.?" Il/\ "'I01.;}';r a person to use the service.
1''''I..rM'~ 0I'1r'i") Oou"l,'\)" nnlfi
l'IIfI')'9": :
21 Any health professional shall ensure the
~I "'I1'i'or 9" I' 'O;/' .). "'II. ;> 1 "1. 9"{j I1C Iv /.<1"'"
advertisement of a health institution whose
o(j ou· I' (I) tTJ I'mS '11\ 0"" , I'mS 1" 'I: 0"" certificate of competence is issued in his name
1'll,IIi Ai.,,)\" iO·{j A')"')\" (ji) Y:i7I.sP1· respect the provisions of sub-article (I) of this
p?hO~,i "'It.:J7'r MIM':: Article.
j"li. ouY:;)'t.ti'! Y;fJlJ9"5 ou<,\Ui IlO'''Il1t'/'WT 81, Medicine and Medical Instrument Advertisement
til "'Ii>;'W'Y" I'm.'! IlI'lUD·f hn?"(~:f. (lly,9" II A health professional may not advertise
hAII-\'<\'I~ ;>C 1''I''I'r. "I'}"j.~o). ...y,~'I.(Jlo<; medicine or medical instrument unless he is a
n"JCJll 'lI'l(Jlo \'0 0 ')'1/-"+ niiA {..;/,Y: direct employee of the manufacturer or
... .l'.l'Im(l). "n>;'(1)")9" ouY:?',. + (l)y,1'" distributor and authorized to do so by the
\',),I1?"<; '00"1('.1' I'I.YM·'I'or'l' M?,1"A?":: appropriate government organ.

~I "'Ii1m·?" 1'm.C; 'll'lon',r I'IS11w· 1''''I,'fI\W'i 21 A health professional may not, in consideration
,!,~,9" 11'79"')' /D·ll'!' O"'lIl1CJ'''' I'I;}'II"'I.(II· of the benefit he may derive, advocate the
0'1';> (l)y,?" Ot. '1'0',·.,. A"ICJ·m+ 1'1'1.1'1(11.') preferential use of any medicine or medical
instrument that would not be clinically
oo.':?~.·)· (I),e9" 1',),\)9"<; ou"'?y 1'(\l'Im
appropriate or cost-effective to the client,
m1''''/,;}' n1'A1' "'1"'1' ..,. 1'1IfI''''I'"::
82, Research Participation
'ifll, OI'"CI'"C llt!on"'t'E
"'Ii>;'W'1'" . I'mS CJI\O""f 0(\0>' '110 0"'1,.1'.1."1 A health professional may only participate in
'!'<;;I''l? P' (~ (II·iI,!, 1\.'" .,.r,: 1''''1,:j'·I'IW· '!'<;." research performed on human subject if the research
""/fl,W") r P'~ ?""1'lC "19"1"'1 O"'ll'l<j: I')\" (I.<j: has wri"en approval after appropriate ethical
t.:n: Y'/"iC; nU'!,'<;-9" 'J""CJj0~'''' ,1'11(1)") 1''1'<;0)' evaluation and is being performed in accordance
TC'H'A I'mfl4' !llf', .l',II'<;A:: with the approved research protocol.

j"e, j'0""j' Y: 2t}: wg.1'" ?"hC llII on ml'olo5 Moollm+
AI "'I')>;'ar9" I'mS Il (\ 0"" .I' 1'\-1'1 tI;>f. 'l'olo I'"
lI.tI nmt-tTJt wy,1'" AII'f;>t IJ-'I.;}' Oontf.,.
'r Q;\, "'I t 01109" h<j:,)->;, ~C-'I;}, llt..tI"1
h"'l')>;'or 9" I'on" CJAY.lCJar 9"I1C CDj09"
Y:;><j: ooml'olo MOo)'::
'1./ Oilt· 'l Af.1. '1 (II. jI"11C I"/'tnl'''' "'Ii>;' arl'"
1'm.C; 'll'lou·f l'1"mI'4'ar') on'f'e I'"I1C<;
n1A'7I\")' I'on·far 1.1.;1\ O"'l,t..~.I'.ar
OOlll-l' oollm')' MO')'::
j"/i. I'''ltl ~I'"~+C; n1t1"1l1-'''' I'onllm+ "19-.;t,
"'I1'i'arl'" I'mS '11'100', 1'''1t1 ~I'"H'i 9"11"+
0"'11:1."1 ~'H'. WilY: OD·~tTJmU; 1I;>'e arOI<;
.1'.1'" "'IiI'r'll'lt}: I' onM I' .h119"<; MA "11'1",).
ntlll'l'l'" "'Ill')' nY,:'j'/:I?D::
'if~, U2'l? ool.JlsPri ill\onilm+
83, Requesting and Providing Professional Support
or Consultation
II In case of any doubt or difficulty and need of
supplementary or higher level of care, a health
professional shall request support or
consultation from any other professionaJ
colleague for the benefit of the client,
21 A health professional consulted by a colleague
shall provide the required professional advice
and service as per the standard of his
profession.
84. Obligation to Serve Despite Belief
A health professional may not refuse on grounds of
personal belief to provide services such as
contraceptive, legal abortion and blood transfusion.
85. ]ssuance of Official Documents

{il "'I'}1arl'" I'm,'! 'l1'l0""J' '!·1A;>f.'} 11 A health professionaJ shall sign official
1''''I.ool'lh·p l''Illt·f·t<; 1'I\.o'l jlUCout- "'I1I'1(C; documents relating to patient care such as
w,m,')' I l'ooY:?~,')' "'Ill'lfi I'l'"lIhC laboratory and other diagnostic requests and
CDI..,,')·; 1'J'.io>;'ar') "'IU1.C' I'lfilT;}'tI results, prescriptions. certificates, patient
records, hospital and other reports after "Tiling
CDj0l'" /\,1\ tTC'Y'1' i Illl'!' 0""1'1' ilO""i<;
his full name.
&.C"'I(J)oi "'Iilt..C MO')'::

, '__ '- 'n

 1l'C :ill.Un ~trl:\ ~.?M· ?IL'~ 'll'T'C Iii 'l'C !~ "'./ ru '1.1"'. Feder:ll Negarit Gazette No. II 24" Janua,y. 2014 Page 7217
'-"-
'~=~====='T"""'======~=~==
11.1 "'I'}t;'ro'9 n
fmS IIMn ..<' 1'.,,0,.1\'1 I.())o~.~>;, 2/ A hcalrh professional shall issue genuine and
I'Uou9" !,.j'Y: (Jlj.W" 1''',li9''',' 9"1I11C rol'~'}' complete sick leave or certificate of illness.
""lim'}' MO'}'::
'ltl. Mup~~'!,'} "'ItI'lf JDl·H''1 1..1'.1\ 86. Prescriptions and 1\1cdirine Dispensing

(il "'I1'i'())o?" rmS ~lIuu,)' M,l',I1"''1 ooro·
hIlA I\f, 1'lII"'I.J'lIh·}·lIar arm,·}· 1''''I)'ar
4'ro·'} auy:~t·), rof,?" 1""4'auuo- I'au~~t,),
l'''l1':·r·)'·) "'11111 I'M'}'?"::
'1.1 "'I'}Ii'ar?U I'm,'1 IIl'1au,,r
1''''I.J'11n·}' l'au~~'L'} "'I1I'lf rol4'''''
.l'.l~'1 O-,rar hf,'!')' aulPlT 1'-I'1I,:J)('1
.l'.l~())O,} I'm04' autn MO')'"
1/ No health professional may prescribe medicine
or fonnulations about which he has no
knowledge about its composition atld
pharmacological action.
au~?t,},'} 2/ A prescription on which a health professional
M*- prescribe shall be standardized and prepared in
accordance with the standard of the institution
and type of the profession .

;:1 "'I 1'i'ar?" 111'1 uo-,r h Mil;£>: 0 If ~

\' Ill. '1 3/ Any health professional shall prescribe
9"h,}J"} IjAIf~ Oll'~4'C 1''''I.J'lIar au~~'L1' medicine registered in the nation'al drug list
01l,h.t,,!? \,au.l'.·?'!.'l· ootlC'IIC unless for compelling reason.
l'-I'ooll71l auln MO')'::
!il "'I'}'i'())o?" uu~)'d' tl"'l'.A '.:I'~ I'-Nlm())o 4/ Any professional dispenser of medicine may
Iltluo-J' "'I'}>;'ro·'}?" O,h.?'!? au'}?': ,rA1'1"i not dispense or keep any medicine obtained
OO.l'.·~~:},'} "'lUI OIl.?" au,l'1l I'tlO')'?"" through illegal channel.

fl. M 41l'il'i ~0I?1~'1 071.:1='} uphl\M 87. Waste Disposal and Disease Prevention
(il "'I')I;'OI·?" \'m,'1 fltlun.J' uoro1~ J'tlO')'') 1/ Any health professional shall dispose of
hm,'; ~,·Jt\"lfl··)· 1''''I.(O''l .f.i'ji'j flt,I'I" disposable healthcare wastes in an appropriate
1'I·"lt1.,?r.'1 1'I1l·lll·,·M· mS 1'I.lltl. "' 70. Olf~ . manner for the sake of himsetf. the client and
the public health . .
oot\h· "'Iil())1>': MM'::
{'(fl.'. (0.1'. 2/ Any health professional shall respect safety
1'1A?y, I h"'7A? y. 01.1'. ·,'7A? y, (OY·?" provisions that ensure the non transmission of
/JoI'1A? f, OJ.I'. Ill. '1 Iltlau· J' On;!,
diseases from himself to client, from clienl to
I. ') Il Y""I\ M: I' "'I. 4' UP Ill' \',. u'l'r)'
~'},np':f") "'lhOC MO')'::
client or from c1ienl to health professional.

'ltg. 07l;t= l''''I.tilhTtl())o lJ-'!.LMou"ltllt 88. Disclosing Prognosis

6.1 I'm,'l 1\.1', J'1I'1 f\.~,}

Ill'lon'J'ar O'1"'}· M,'j: 1/ A health professional shall explain the nature
r
o"'I.e A ro f,?" 0M ~ n7I;!' til T Ij "'I. '} 1'.,. and possible outcome of the terminal or sever
l'u009" IJ'''TC; On;!'ar fOUlIh·)'tlar'} illness to the patient or, in case of a minor or
())om,')' tlTIJ"'I.ar rof,?" TIJ"'I.())o IIMau mentally ill person, to the guardian.
M?" Yt\.I'.lil rof,?" I'hl.?"C' (hOO?"''''i'
hlf~ tlMlltar ft.1t\lttl1' MilA ::

fll I'ILU h'}4'7\ '}O·iI h,} '~7\ (Ii) ~')?'/, o''l'C?'' 2/ Notwithstanding the provisions of sub-article
fm,C; Iltl-J'ar O'1"'}' h'\.'j: I\.e ttl'1 ft.~'} (I) of this Article, a health professional may
O"'lf,l'A ro.e?" OM.I'.' "7iT I'TJ't\') liar only communicate the nature and possible
I'07iT 11'''T'1 071;1-1))' 1''''I.,rllh'}lIar') outcome of the terminal or sever illness to
())om,.). tlTlJ"'I.lI)· UO')lC Oau')!,.lI
family members of the patient where he
Maul ,:J ,:J .}. T lJ "'I. ())o t-lI'') MIlt\ 1I/'r
believes that the patient may haon himself due
lIOU~ .eu')') ODl~ I'ITII"'I.o>- 'l.-,.Mt /oIl1\')'
111' tlS1C J?'fl\t\:: to emotiona1 instability.

'ltll. 1.11 t\ ') 1.'l uo-J' 'I: J'to. If ~ -I' "lIlC,) tTCT 89. Reporting of Impairment and Unprofessional
•
1''''1~ l "I "I Y.;t- Conduct
"'I')'i'(O'?" \'m,C; Ill'lau·,r 1''''I.h·/'I\--)-·) h"lll·n Any health professional shall report the following to
1\1I11~ hilA t?'C')' o~Y:l'7 MIl')':- the appropriate organ:
 Federal Negarit Gazette No. 11 24th January, 2014 Page 7218

fil MltI 1'1''1'';1·tI l1t'1- ,l'UD~Il')") I't'lA I'm,'; 11 an impairment in another health professional if
flt'lolJ·.n I.tltl i
he is convinced that such professional is
impaired;
~I I''''L,I'aH'(/)' (/)f,9" 11.1',4. I.'M.,!'(/)·:Y 1"/·.I'.l1 2/ his own impainnent if he is aware of it or has
htf'/ (/).1',9" n'hlllmlar I.hll· 9"h1,1'1' been publicly infonned, or he has been advised
Ort· 'I bll.Ln'J, ·/·10.W··) j'; :>~: 1.·}-'l.m,l'.:Y by colleagues to obtain help in view of an
9"IIC 1'·I·t'\'JOm· h tf~ I't·O··) I.lltI: alleged impainnent;

U I'OD·J' /'.:Jo.l'.' I't'I.t'I(D. mf,9" 1'00',1' t.:I'-'\. 3/ the provision of health service by a person
I' ;1'11'.0')' (/)f,9" Nc'llllfl'l' c'lar I'mS without professional license or whose
professional license has been suspended or
/'1t1"11l'+ I.I'c'lm ootf',·') I 1.'i
revoked; and
§I 1'11.0'1 flt\oo·.n O?'g'ar9" -,I''f ,l'tltf~ I"~
4/ any unprofessional conduct of another health
9""I'lC)::
professional.
h'f:tI Mr
M·t-1!"'Ir PART SEVEN

j. !1M2'''' "'ll2-'1~U."()bC_.@l.j'± INSTITUTIONS

iii "'I')';'m'9" t\(/)' 1'11:1'1' "'Il:>1"~ 9"fltlC 90. Certificate of Competence

(/) L 4' 1- /'''1'111 l-jt\ lD- /, l-j tI <'1,1"1'1
1/ No person may establish and run institution
M:4!'1" fit· 'IJ', ooO"'l?-')' /'J','ftl9":: without obtaining a certificate of competence
~I II"'1')'i'(/)'9" '1-:1:9" Nt\m 1'11:1'1- "'Il,n~ from the appropriate organ.
9"flhC (/)L4'1' Ol',}oo'" oo:N.fI M01-:: 2/ A certificate of competence issued to any
institution shall be renewed annually.
rl "'I1'i'ar9" r*9n 1'11:1"[' "'Il:>7~ 9"flhC
(/)l.,,')· O(/)t\.I'.I11- oofiotC')' 170M'''' fI?-lD-1 3/ Any institution shall undertake its business in
"'I h 'ian J',';'C n:1' tI : : accordance with the requirements on the basis
of which its celtificate of competence issued.
21 /'''Ifll1 ,l't\(/). /'l-JtI 1'11:1")' "'Il:>1"i. 9"flhC
(/)l4")' oa'l.I~'1'n-l· (/).1',9" 1l"'L,I'.~fIn1- tl1. 41 The appropriate organ may issue or renew a
I'9"C1:1 (/)J!,9" I'h1t1"11l-1:1 '}J',~1'i certificate of competence subject to restrictions
hoo&·l')· i M1Jl:P:')' i hhoo;f'f1- 1.'i 1l.1l-'f on the type of the product or service, means of
Mot"1. I'tf'1- !W"C'I: roJ',9" hh1t1"lll·'" production, processing, storing and any other
'1'&")''i !,.U1~')· pC I"/-,!',I'll- "'I'i'flD-19" necessary conditions relating to the quality and
'}J',~')' IJ-'!.;I·?Jf1
11.,1' fI.,,9"'1' J', 'f'l tI : :
1.11. .,.*- "I$!.:1' safety of the product or service.

(;1 1'11:1'1' "'IlP7"i. 9"flhC rol"")'1 /'''Ifll1

Ij II lD- /, Ij tI ot:l'!': lD-al, 11"'11'i'lD-9" 00 till- 5/ It is prohibited to transfer in any manner a
II{l M' 'i' (/)71 "'I fI.,."" <j: /, J',;f tl9": : certificate of competence to a third party
without the penn iss ion of the appropriate organ.
'Ii. 1'.11-"±-_"'llZL·''I..2''1JIlc...JIJ.l.tl.L1I11ap ooilfi
91. Surrender of Certificate of Competence
"'IW(/).9" 1'11:1'1- "'Il P 1 ~ 9" flhC (/)l4' 1-
1':1'1.1'.l1r 1 I'-/-lPllIll')' roM" 1.!':"Ir r'/'hllh Any institution whose certificate of competence is
IIllr roM· 1"?-(/)'1 f*lm "'*9" 1'11:1'T revoked, cancelled or denied renewal or which has
"'Il P 1 ~ 9"11 h C ro t.4' 1: 1 /'''11)11 ""lD- /, IjA
ceased operation shall surrender its certificate of
0000l1li MO'r::
competence to the appropriate organ.
jl. MI)II-,I'?J'f I'm.'i 9"Coot-

iii "'1')';'(/)'9" '''*9"

h·/··/A.'JJ', ;JC "I·n·~·)·
92. Professionals Health Examination

,l'lIar I'm. .. '11100'.1'1 (/)J',9" 9""1·11 Mp~1 11 Any institution shall make health professional
11',.*9" (/)·fI'1' hoo4'm<;. Ilt.·.,. 1.1-'1.U·9" or food handler who has contact with clients to
111''100'" . hl1.1'./'J',.1l.!lb.l':II IlM'~C I'm.'i undertake pre-employment and annual medical
9"Coot· .,.')-'l.fY.C"I "'I!':l"l Mil')':: examination'-except for HIV /AIDS.

-"'~- .,..,..,
---"'"
 _.. -
Federal Negarit G37.ctle No.1 J 24\h January,2014 P<1ge 7219

!l.1 "'1'I'i'ro' 9" rills 'ltloo'J' OIl.U n'HK' '1M' 21 No health professio nal may undertake medical
h 14'lI' (~) oow I. 'l' t\t,(r rills 9"Cou{" examination for himself in accordance with
"'1Y:I.'1 hj'A'tl9":: sub·article (I) of this Anicle.

t:1 "'1'I'i'IJI-9" 9"'111 nll;l)'; n9" '111 0 "'l.1' ... tI <i: 31 Any food handler shall notity the institution
n71;t' n"'1.J'1/Il'l· '/.11. (\01-*00' "'111'CDP where he is infected by food borne ·
.e'i'cn;t'tI:: communicable disease. Any food estoblishment
shall screen a food handler infected by food
borne communicable disease.

fJJ "'1'}'i'IJI-9" r9"'111 1'*9" n9"'1'o n"'1.1' ... tI<i: 4/ Any food establishment shall remove any food
R7i;t' r·t-J'I! oolf~' r;t'cD4'1 r9"'111 M1:>;t>; handler who is infected by food borne
07i;hD' r"'lY,.f· ... tI'i:o·l· 1,1.:<1 Mh.I.CfI Y:l.fI communicabJe diseflse from activities involving
h9"'111 :>C 1hh. '1''I'J'1JI- flt.?''T ?,'I-'I. 7t1t1 contact with food until the disease becomes non
"'IY:I.'1 Mn'l':: communicable.

al I]tlp'N'1~' h·r7t1;J.!.'. :>C '1TH'). J'tl1JI-1 51 The Authority shan issue directive on the type
rills ~tI-J' roy.9" \'9"'111 Ml?»: 9"Coot. of medical examinations that a health
Il.J'.I',C"lO·). M"'l. 71]1JI- rn71.r nj.'. ~-). professional or food handler who has contact
n-/,outlll-I' llCllC ououtJ' J'CD"!tI:: with clients shan undenake.

11:. M1'*9" ",,{lloCf.'f'i htlM?''f 93. Institution Requirements a nd Prohibitions

iiI "'I-I';'IJI-9" -1'<':9" f''''I.tlJi''J'1JI- 1 7-:tt 1'l'1. 1/ Any institution shall develop intemal waste
~7r: ')' '1 .jI7i7i?' ';f (\ un.jl "!Ill C IJI-fI"! 'l! r .jI7i 7i management system to manage its hazardous
hYY'lf'1 h01:>7Y: P'C~"'- (\.<;'I.IJI- ,I'.1l]tI:: substances and wastes.

II "'11'i'CD'9" -f'*9" hlJl-~ MC 9"'11l'l CDj.'.9" 2/ An exporter institution shan obtain special
ouY::>'d-1 n"'l{lou"!-)- M'l';t' CD~ t\A MC permit from the Authority for transiting
t\au ... h /II] t\P' A "!.,. A r. 4. Ji' Y: "'1"11'). medicine or food from foreign country to
Mn-).:: another country.

1'.1 "'11';'01'9" -"'1;9" NMM (]lj.'.9" I'MtI"I(\o-). 3/ No institution may impon, keep or distribute
7.1\.1JI- J't\lon-)· 9"'1·(n CDj.'.9" 001::>'1.-).'1 prohibited or expired food or medicine.
"'I{lao"l')" noY'l' w,e9" "'II'lt,lXl.-}· h.e
'):tl9": :

ij,/ "'11';'01'9· Mou(.T.l, roy.9" )';9·... hhM.y. 41 No wholesale or impon institution may
'1'*9" i'11Ji'-)' "'11.?7"'L 9"{lhC CDI.4'-)· distribute food or medicine for a person with no
M. fl IJI- 1'1 IJI- 9""l1l'l m .e 9" 001::> 'I. .) •.) "'I M. cenificate of competence.
loA h.e'ftl9"::

(;1 "'11'i'IJI-9" r .1'"1'1 C tl9" 9" I: 1'1 "'l. J'f.C'1 '1' "'1 t 5/ Any health institution which permits a student
i' Ill. '1 n 7A '1 (\0 ·l· ?, 1-'1.1'1 'l' r.t 4' ~ i' Ill.'1 '1' *9" on practical training to provide health service
1''''I{'ro· O;t","'I.w· ... y. fl"'l.J'.I',CfllJl- '1-.<1-). shan be responsible for any damage the student
:>II.1.H' J'.'~CO;J,tI:: may cause to a patient.

h<i:A il9"')·). PART SEVEN

Af. Af. 1:1?1?''f MISCELLANEOUS PROVISIONS

~!i. "",,;II i'oo{lm-r '19.;t' 94. Duty to Furnishing Information

iiI "'11'i'01·9· i'1ll.'1 I]flou·f n"/lJl1 I]fllJl- n"A
O"'l'1:far9" 7.tL rno' ,!' fit· &,Ji'-,\-' ) ?,1-'1.,!' ... .e
Wj.'.9" rt.fl·1 mj.'.9" \'1\,<'\ lJt\uo'f -J''f
?")i'fI,4>(~ 1''''I.fllY. uul:<1 h')-'l.f4'Cll 1l.1ll1'i'
l'au'I'I]OC "I$'.;}. MO')'::
11 Any health professional shan cooperate with the
appropriate organ whenever requesred to show
his professional license or provide information
about his professional performance or that of
others.
 -
Federal Ncgari( Gazette No. 11 24lh January, 2014 Page 7220

fl fJl'I?'tllTJ~' fllLU h14'7i 1frll h14'7i (Ii) 2J The appropriate organ shall keep the
ov!pd' J'11or1 ovG>: nu"? I-ttl1't.4'1. confidentiality of information obtained in
nll'~"'c O"'l.il'l'C <fOmf1:r Mn7'" accordance with sub-article (1) of this Article-
unl ess otherwise permitted by Jaw.
'Ii, "Tc'l' 1''''11;1.'1 '71'.;1'
95, Duty to Report
jil "'I1'i'or9" {lco' h'}Y: 1'/1\,'1 Ilil-J' 1'/1\,'1
1/ Any person who believes that a health
1I''I.;t-or 'n-/< 1''''I,J'1.C?or Muvlf'r1 COM"
professional is unfit to practice or commils
ov'J''!! ytlU"/ ?'~ Y""IfJC ovt.1.uv·'>
unprofessional conduct shall notify the
lJov~O '}' h"ll]lI 'I(leD' hlltl 1''''I<'IeD1> "I~;t­
appropriate organ.
Mn'}'::
21 Any person who in good faith nolifies the
11/ OILU h'lo/>\' ')frll h')4'>\' (Ii) UOIPG'/' h"lfJlI appropriate organ in accordance with sub-article
'I(lor Itl-ttl n:r'i tI(l'l uol.Jl I'l'Im {lor nu"? (1) of this Article may not be legally liable.
1'mJ'<t hJ!,lf')Y"::

n. l!~.:'IkT_t!<j:J' 96. Service Fees

"'11>;' co- 9" {lCO' I'tID.J' fit· t.JI>Y: CO~Y" NIJ1>7' Every person shall pay service fees to the
"'I G:n "'I. 9" II h C CO I. H· 1'1"'1 or 1TJ7' CO J!,9" appropriate organ at the rate approved by
1'1"'1<'11.111 ouY:;:"I;l'1 {l"'lllau1l?'n aJJ!,9" t\il- l' . government for obtaining or renewing professional -
9"llhC aJl.N·)'·')'I MtI"II'I·,H1 (I"'I"I1r license or certificate of competence, registering
nov1"1?'-l' n1..I'.o/' ,,'au'> tID{ll.')' h"lfJlI 'Il'Ior medicine or receiving other certificates and services.
h!JtI I' h?tI "1(1")' h<J:, f!,h<J:'ItI::

U. I1I1T7i<;-'I Tt.Il"'Ur flII"'If.<;6-Tor u1l' 97. Repealed and Inapplicable Laws

/il l''''I.h-l'(I--)· ntl.U .I'.'HI '~7il.'I'tI:- 1/ The following are hereby repealed:

Il} I'/I\,~' h7t1"lt'I-,l' '''*9'' t.JI>Y: MITJ'l''I a) the Licensing and Supervision of Health
of:'l''l'C 1''''I.'LIl')·C:''''· 9"hC o.r .I'.1'n Service Institutions Council of Ministers
"''l'C H~!!IIi!!ii'l! h'l Regulation No. I74/ 1994; and

II) rn.-rl"fI'Y illS fJlI-Y?Jr oo"'lhcr b) the Ethiopian Health Professionals Council
1'Cl't "'1**"'1.,1' r"'l. 'I.1l·h:l' 9"hC o.r Establishment Council of Ministers
.l'.1-(] 4!'l'C ~!ilIiir'.l!i::
Regulation NO.76/2002 .

21 No regulation. directive or customary practice

r.1 J!,Ul .1'.111 1''''I.JI>G1 "'I,'i'or9" .f.111!
shall. in so far as it is inconsistent with this
oouot:J' aJJ!,9" I'hIJJ6-C tl9"Y: flIl.u .f.111
Regulation, be applicable with respect to
(lI'll'l' I'TOD(lh1> ?·.II1"1'-1 n"'l.ovllh+ Tt.
maners provided for by this Regulation,
''''I.~,r hJ!,<;l.aJ·~u: :

,1:. oouo_?Lf~ITJ:Le~~ 98, Power to Issue Directives

1l(l?'tllTJ~ ' J!,U1 .1'.111 11"'111&.1.9" 1''''I..,IlUNI- The Authority may issue directives necessary for the
auov? J' ?J:j:1 lI.'aJlTJ f. 1'-'ItI:: implementation of Ihis Regulation.

7/1. .1'.111- I''''I..K'IOr 'I.!l. 99. Effective Date

f.U .1':111 n.l...r,t·tI ~;JM' ;J11.1TJ ;t-,)-qu haJlTJn')' This Regul ation shall enter into force on the date of
""1 ~Y"C' 1'1.'1 Y,lf'itl:: publication in the Federal Negarit Gazene,

Mil MfJ 'l'C J.~ 4'') f71~ 't.9" Done at Addis Ababa, this 24'~ day of January, 2014.
;:. J!.II"'I c J'9" .1'.1\ II ~ HAILEMARIAM DESSALEGN
1'n.'}·I"A·' .I...I'.6-II'/! )(. quht-fl.J',/! PRIME MINISTER OF THE FEDERAL
DEMOCRATIC REPUBLIC OF ETHIOPIA
"Tl1l1.h m'l''IJ!. "'I.. 'I.llrC